BO YTECUC AN TOANTOirc PHAM

C0NG HOA XA HOI CHU NGHIA VIET NAM Doc lap - Ttr do - Hanh phuc

s6^^?/kl-attp Ha Noi, ngayJzJ- thdng 8 nam 2019

KET LUAN THANH TRAVe vice chap hanh phap luat ve an toan thuc pham trong san xuat, kinh

doanh, nhap khau, quang cao thuc pham chuc nang/thire pham bao ve suekhoe tai tinh Nghe An va Ha Tinh

Thuc hien Quyet dinh thanh tra so 376/QB-ATTP ngay 31/5/2017 cua Cue trudng Cue An loan thuc pham ve vice thanh tra vice chip hanh phap luat ve an toan thuc pham trong san xuat, kinh doanh, nhap khau, quang cao thuc pham chuc nang/thuc pham bao ve sue khoe tai tinh Nghe An va Ha Tinh tu ngay 10/6/2019 den 14/6/2019 Doan thanh tra neu tren da ti<§n hanh thanh tra tai 05 co so tai tinh Nghe An va 02 co so tai tinh Ha Tinh.

r r r A oXet bao cao ket qua thanh tra ngay 05/8/2019 cua Trudng doan thanh tra, y kien giai trinh cua doi tuong thanh tra, Cue trudng Cue An toan thuc pham ket luan nhu sau:

I. KHAI QUAT DAC DIEM TINH HINH TO CHiTC, HOAT DONG CO LIEN QUAN DEN NOI DUNG THANH TRA CUA 07 CO S0 LA DOI TUONG THANH TRA

1. Cong ty TNHH Thanh Ngoi, dja chi: Khdi 5, Thi tran Phd Chau, Huyen Huong son, tinh Ha Tinh

Giay chung nhan dang ky kinh doanh so: 3001855444, dang ky lan dau ngay 05 thang 01 nam 2015 do Phong Bang ky kinh doanh cua So Ke hoach va Bau tu tinh Ha Tinh cap.

Tong so san pham thuc pham chuc nang/ thuc pham bao ve sue khoe do/ f y r o \

co so edng bo tai Ciic An toan thuc pham: 05 ho so edng bo san pham, 03 ho so cong bo con hieu luc.

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2. Cong ty co phan Buoc Ha Tinh, dia chi: so 167 dudng Ha Huy Tap, phudng Nam Ha, Thanh phd Ha TTnh, tinh Ha Tinh

Giay chung nhan dang ky kinh doanh so: 3000104879, dang ky lan dau ngay 29 thang 12 nam 2004, thay doi lan thu 15 ngay 28/5/2019 do Phong Bang ky kinh doanh cua So Ke hoach va Bau tu tinh Ha TTnh cap.

Tong so san pham thuc pham chuc nang/ thuc pham bao ve sue khoe co so edng bd san pham: 49 hd so edng bd trong do 34 hd so edng bd con hieu luc, 15 hd so edng bd het hieu luc.

3. Cong ty TNHH Thuong mai va edng nghe BKH, dia chi: So nha 338, Budng Le Viet Thuat, Xa Hung Ldc, Thanh phd Vinh, tinh Nghe An.

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Giay chung nhan dang ky kinh doanh so: 2901956651 dang ky lan dau ngay 16 thang 11 nam 2018 do Phong Dang ky kinh doanh cua So K6 hoach va Dau Ur tinh Nghe An cap.

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Tong so san pham thuc pham chuc nang/thirc pham bao ve sue khoe do co so cong bo tai Cue An toan thuc pham: 07 san pham, cac san pham dang ky san xuat tai Cong ty co phan dugc pham Vgas, cac ho so cong bo con hieu luc.

4. Cong ty co phan Sata Viet My, dia chi: So 33, dubng Luc Nien, Phudng Vinh Tan, Thanh pho Vinh, tinh Nghe An

Giay chung nhan dang ky kinh doanh so: 2901954206 dang ky lan d4u ngay 29 thang 10 nam 2018 do Phong Dang ky kinh doanh cua So Ke hoach va

\ r

Dau tu tinh Nghe An cap.Tong so san pham thuc pham chuc nang/thirc pham bao ve sue khoe do

co so cong bo tai Cue An toan thuc pham: 06 san pham, cac san pham dang ky san xuat tai Cong ty dupe pham va thuong mai Phuong Dong (TNHH) va Cong ty TNHH thao dupe Thanh Hang, cac ho so cong bo con hieu luc.

5. Cong ty CP Dupe - Vat tu y te Nghe An, dia chi: So 68, Nguyen Sy Sach, phuong Hung Phuc, thanh pho Vinh, tinh Nghe An

Giay chung nhan dang ky kinh doanh so: 2900491298, dang ky lan dau ngay 30 thang 01 nam 2002, thay doi lan thu 6 ngay 03/01/2018 do Phong Dang ky kinh doanh cua So Ke hoach va Dau tu tinh Nghe An cap.

Tong so san pham thuc pham chuc nang/ thuc pham bao ve sue khoe cor t \ r

so cong bo: 18 san pham, 18 ho so cong bo con hieu luc.6. Cong ty TNHH Dong y An Khanh Tam, dia chi: So nha 27, dubng 8,

khu do thi Tecco Vinh Tan, phuong Vinh Tan, thanh pho Vinh, tinh Nghe AnGiay chung nhan dang ky kinh doanh so: 2901927153 dang ky lan dau

ngay 26 thang 02 nam 2018 do Phong Dang ky kinh doanh cua So Ke hoach va

Dau tu tinh Nghe An cap.Tong so san pham thuc pham chuc nang/thirc pham bao ve sue khoe do

co so cong bo tai Cue An toan thuc pham: 02 san pham, cac san pham dang ky san xu^t tai Cong ty co phan dupe pham Vgas va Cong ty TNHH san xuat dich vu thuong mai Binh An; cac ho so cong bo con hieu luc.

7. Cong ty Co Phan Khoa Hoc Xanh Hidumi Pharma, dia chi: Xom 6, Xa Quynh Luong, Huyen Quynh Luu, tinh Nghe An

Gmy chung nhan dang ky kinh doanh so: 2901494848 dang ky lan dau

ngay 27 thang 02 nam 2012, thay doi lan thu 7 ngay 05/12/2016 do Phong Dang ky kinh doanh cua So Ke hoach va Dau tu tinh Nghe An cap.

Tong so san pham thuc pham chuc nang/thirc pham bao ve sue khoe co so

cong bo: 05 san pham, 05 ho so cong bo con hieu lucII. KET QUA KIEM TRA, XAC MINH1. Cong ty TNHH Thanh Ngoi, dja chi: Khoi 5, Thj tran Pho Chau,

Huyen Huong son, tinh Ha Tinh(1) Ho so1 hanh chinh, phap ly cua co’ so:Giiy chung nhan co so du dieu kien ATTP so: 000093/2015/ATTP-

CNDK ngay 05/6/2015 do Cue An toan thuc pham cap san xuat thuc pham chuc2

*> ' r m

nang, thirc pham tang cuang vi chat dinh duomg dang vien nang ciing, dang long.

(2) Cong bo san pham:or o o

Theo bao cao cua Cong ty, Tong so san pham thirc pham chuc nang/ thirc pham bao ve sue khoe do co so cong bo tai Cue An toan thirc pham: 05 san pham, 03 ho so cong bo con hieu lire. Tai thoi diem thanh tra, Giam doc bao cao

r o

Cong ty dang ngung boat dong san xuat, kinh doanh thirc pham bao ve sue khoe 12 thang (tu ngay 12/01/2019 den 12/01/2020) theo Giay xac nhan ve viec doanh nghiep dang ky tarn ngung boat dong kinh doanh cua Phong Dang ky kinh doanh So Ke hoach va Dau tu tinh Ha Tihh cap, cac ho so con hieu lire baogom:

- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Vien Khop Thanh Ngoi, Giay xac nhan cong bo phu hop quy dinh an toan thirc pham so 35342/2016/ATTP-XNCB ngay 20/12/2016.

9 0^ O

- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Tang can Hoang Thong, Giay xac nhan cong bo phu hop quy dinh an toan thirc pham so 25301/2016/ATTP-XNCB ngay 05/10/2016

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- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Hoang Trung dubng Da Day - Dai Trang, Giay xac nhan cong bo phu hop quy dinh an

toan thirc pham so 19383/2016/ATTP-XNCB ngay 19/8/2016.9

Tai thoi diem thanh tra, Cong ty chua co van ban thong bao viec tarn ngung boat dong san xuat, kinh doanh san pham thirc pham chuc nang/thuc pham bao ve sue khoe.Thuc hien yeu cau cua Doan Thanh tra, ngay 17/6/2019 Cue An toan thirc pham nhan duoc cong van (so den 795) cua Cong ty ve viec tarn ngung boat dong kinh doanh.

(3) Bieu kien bao dam ATTP:Tai thoi diemThanh tra co so san xuat dang ngung boat dong, Doan thanh

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tra ghi nhan tai co so khong co san pham san pham thirc pham chuc nang/ thirc pham bao ve sue khoe doi voi 03 san pham ho so cong bo con hieu lire neu tren.

2. Cong ty co phan Duoc Ha TTnh, dja chi: so 167 dirong Ha Huy Tap, phuong Nam Ha, Thanh pho Ha TTnh, tinh Ha TTnh

(1) Ho so’ hanh chinh, phap ly cua co* so:- Giay chung nhan co so du dieu kien ATTP so: 000607/2017/ATTP-

CNDK ngay 26/6/2017 do Cue An toan thirc pham cap cho san xuat, kinh doanh

thirc pham.- r r r ^ *

- So ngubi lao dong: 616 ngudi. Trong do: True tiep san xuat: 150 ngubi (36 ngubi lam true tiep day chuyen thirc pham).

- Gidy xac nhan kien thuc ve ATTP: 37 ngubi- Gidy xac nhan du sue khoe cua chu co so va cua ngubi true tiep san

xuat, kinh doanh thuc pham: 37 ngubi- Gidy chung nhan he thong quan ly chat luong ISO 9001:2015; Giay

chung nhan thuc hanh tot san xuat thuoc GMP, GLP, GSP -WHO cua Cue

Quan ly Duoc - Bo Y te.

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(2) . Cong bo san pham:Theo Bao cao cua Cong ty, tong so san pham thuc phim chuc nang/ thuc

pham bao ve sue khoe co so cong bo san pham: 49 h6 so cong bo trong do 34 h6 so cong bo con hieu lire, 15 ho so cong bo het hieu lire trong do:

+ San pham dang san xuat, kinh doanh: 12 san pham + San pham chua san xuat, kinh doanh: 22 san pham- So san pham co Giay xac nhan cong bo phu hop quy dinh an toan thuc

pham nhung da het hieu lire: 15 san pham.- So san pham khong co Giay xac nhan cong bo phu hop quy dinh an toan

thuc pham/Giay tiep nhan dang ky ban cong bo san phdm: 0 san ph£m.(3) . Ghi nhan san pham:Doan thanh tra danh gia ve ghi nhan cua 05 san phdm la mau luu tai Cong

ty ghi nhan:X 't X X a 93.1 So san pham duoc kiem tra ve ghi nhan: 05 san pham

3.2 So san pham co nhan ghi dung quy dinh: 05 san phamX •> X r •/s/* 93.3 So san pham co nhan ghi khong dung quy djnh: 0 san pham

3.4 So san pham khong co nhan theo quy dinh: 0 san phamCu the:+ Thuc pham bao ve sue khoe vien giai Rugu Hadiphar do Cong ty cong

bo duoc Cue An toan thuc pham cap Giay xac nhan cong bo phu hop quy dinh an toan thuc pham so 3906/2017/ATTP-XNCB ngay 02/02/2017. Noi dung ghi nhan phu hop voi nhan trong ho so cong bo duoc Cue An toan thuc pham xac nhan.

+ Thuc pham bao ve sue khoe Com vi sinh Prima Bio do Cong ty cong bo duoc Cue An toan thuc pham cap Giay tiep nhan dang ky ban cong bo san pham so 2271/2019/ BKSP ngay 07/3/2019. Noi dung ghi nhan phu hop voi nhan trong ho so cong bo duoc Cue An toan thuc pham xac nhan.

+ Thuc pham bao ve sue khoe Rosabela Collagen Gold do Cong ty cong bo duoc Cue An toan thuc pham cap Gray tiep nhan dang ky ban cong bo san pham so 4512/2018/ BKSP ngay 18/7/2018. Noi dung ghi nhan phu hop voi nhan trong ho so cong bo duoc Cue An toan thuc pham xac nhan.

+ Thuc pham bao ve sue khoe Bai trang Hadiphar do Cong ty cong bo duoc Cue An toan thuc pham cap Giay tiep nhan dang ky ban cong bo san pham s6 4514/2018/ BKSP ngay 18/7/2018. Noi dung ghi nhan phu hop voi nhan trong ho so cong bo duoc Cue An toan thuc pham xac nhan.

+ Thuc pham bao ve sue khoe Gastsea do Cong ty cong bo duoc Cue Antoan thuc pham cap Giay tiep nhan dang ky ban cong bo san pham so4509/2018/ BKSP ngay 18/7/2018 va cong van bo sung so 54/CTB ngay

• • • '08/8/2018 cua Cong ty. Noi dung ghi nhan phu hop voi nhan trong ho so congb6 duoc Cue An toan thuc pham xac nhan.

(4)Dieu kien bao dam an toan thuc phamCong ty co phan Buoc Ha Tmh dang trong qua trinh hoan thien co so dat

yeu chu “thuc hanh san xuat tot” (GMP) thuc pham bao ve sue khoe. Ngay 18/5/2019 Cong ty duoc Boan tham dinh thanh lap theo Quyet dinh so 274/QB-

ATTP ngay 23/4/2019 cua Cue An toan thirc pham thdm dinh Di^u kien an toan thirc pham doi vdi ca sa dat yeu chu “thuc hanh san xuk t6t” (GMP) thirc pham bao ve sue khoe. Ngay 01/6/2019 Cong ty da gui Cue An toan thuc ph&m bao cao Idiac phuc viec trien khai ap dung “thuc hanh san xudt t6t” thuc pham bao ve sue khoe.

(5) Quang cao san pham:Theo bao cao cua Tong Giam doc Cong ty, Cong ty co duy nhat website

hadiphar.vn, tp thdi diem thanh tra website hadiphar.vn khong quang cao san pham thuc pham chuc nang/ thuc pham bao ve sue khoe (co ban in man hinh tu website hadiphar.vn kem theo).

(6) Lay man Idem nghiem: Doan thanh tra khong lay mau.3. Cong ty TNHH Thuong mai va cong nghe DKH, dja chi: So nha

338, Duong Le Viet Thuat, Xa Hung Loc, Thanh ph6 Vinh, tinh Nghe An.Cong bo san pham:Theo bao cao cua Cong ty, tong so san pham thuc pham chuc nang/thuc

pham bao ve sue khoe do co so cong bo tai Cue An toan thuc phdm: 07 san pham, cac san pham dang ky san xuat t^i Cong ty co phan dugc pham Vgas, cac ho so cong bo con hieu luc. Tai thdi diem thanh tra, Giam ddc Cong ty bao cao, ke tu khi cong bo, Cong ty chua san xuat, kinh doanh cac san phkm thuc phihn bao ve sue khoe da cong bo. Cac san pham Cong ty da cong bo bao gdm:

- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe Myoko, Giay tiep nhan dang ky ban cong bo san pham so 6427/2019/ DKSP ngay 05/6/2019.

7 y\ X / 9- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe Thanh Giong, Giay tiep nhan dang ky ban cong bo san pham so 6429/2019/ DKSP ngay 05/6/2019

7 7 •>

- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe Myoko mama, Giay tiep nhan dang ky ban cong bo san pham so 6428/2019/ DKSP ngay 05/6/2019

- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe Hprotect, Giay tiep nhan dang ky ban cong bo san pham so 6240/2019/ DKSP ngay 03/6/2019

7 7^ 7

- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe Tumor Care, Giay tiep nhan dang ky ban cong bo san pham so 209/2019/ DKSP ngay 03/01/2019

X X r x ^ /v r •- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe Natinfla, Giay tiep nhan dang ky ban cong bo san pham so 4218/2019/ DKSP ngay 22/04/2019

7 7 7

- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe DKH Care, Giay tiep nhan dang ky ban cong bo san pham so 451/2019/ DKSP ngay

09/01/2019.^ # 7

Doan thanh tra ghi nhan tai thdi diem thanh tra tai Cong ty khong co san

pham thuc pham bao ve sue khoe.

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4. Cong ty co phan Sata Viet My, dja chi: So 33, duong Luc Nien, Phuong Vinh Tan, Thanh pho Vinh, tinh Nghe An

Cong bo san pham:Theo bao cao cua Cong ty, tong so san ph4m thirc ph4m chuc nang/thirc

pham bao ve sue khoe do co so cong b6 tai Cue An toan thirc phdm: 06 san pham, cac san pham dang ky san xudt tai Cong ty dugc phdm va thuong mai Phuong Dong (TNHH) va Cong ty TNHH thao dugc Thanh H^ng, cac h<5 so cong bo con hieu lire. Tai thbi diem thanh tra, Giam d6c Cong ty bao cao, ke tu khi cong bo, Cong ty chua san xuat, kinh doanh cac san pham thirc phdm bao ve sue khoe da cong bo. Cac san pham Cong ty da cong bo bao g6m:

- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Evitas Spa Giay tiep nhan dang ky ban cong bo san pham so 1951/2019/ DKSP ngay 26/2/2019.

9 A A A ^- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Pesomum gold, Giay tiep nhan dang ky ban cong bo san pham so 5169/2019/ DKSP ngay 15/5/2019

9 9 9

- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Thong huyet duong nao GT2, Giay tiep nhan dang ky ban cong bo san pham s6 5841/2019/DKSP ngay 27/5/2019

9 9 9

- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Vitamin 5B Arginin Plus, Giay tiep nhan dang ky ban cong bo san pham so 5548/2019/ DKSP ngay 20/5/2019

9 A f 9- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe Colikids, Giay tiep nhan dang ky ban cong bo san pham so 4914/2019/ DKSP ngay 09/5/2019

- San pham thirc pham chuc nang/ thirc pham bao ve sue khoe vien bo mau Antomax, Giay tiep nhan dang ky ban cong bo san pham so 5207/2019/ DKSP ngay 15/5/2019

Doan thanh tra ghi nhan tai thoi diem thanh tra tai Cong ty khong co san

pham thirc pham bao ve sue khoe.5. Cong ty CP Dugc - Vat tu* y te Nghe An, dja chi: So 68, Nguyen Sy

Sach, phuong Hung Phiic, thanh pho Vinh, tinh Nghe An (1) Ho so’ hanh chinh, phap ly cua co’ so*:GiSy chung nhan ca sa du dieu kien ATTP sty. 00510/2018/ATTP-CNDK

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ngay 27/8/2018 do Cue An toan thirc pham cap cho san xuat thirc pham.So nguai lao dong: 21 nguoi. Trong do: True tiep san xuat:20 ngudi (lam

true tiep day chuyen thirc pham); Gian tiep: 01 ngudi Giay xac nhan kien thuc ve ATTP: 20 nguoiGiay xac nhan du sue khoe cua chu co so va cua ngudi true tiep san xuat,

kinh doanh thuc pham: 20 ngudi(Bao cao ngay 12/6/2019 cua Cong ty kem theo).

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(2) Cong bo san pham:“) r t •>

Theo Bao cao cua Cong ty, tong so san pham thuc pham chuc nang/ thyc pham bao ve sue khoe co so cong bo: 18 san pham, 18 ho so cong b6 con hieu lire trong do:

+ San pham dang san xuat, kinh doanh: 13 san pham + San pham chira san xuat, kinh doanh: 05 san pham

r •> r r

- So san pham co Giay xac nhan cong bo phu hop quy dinh an toan thuc pham /Giay tiep nhan dang ky ban cong bo san pham nhung da het hieu lire: 0 san pham.

- So san pham khong co Giay xac nhan cong bo phu hop quy dinh an toani r r ft t

thuc pham/Giay tiep nhan dang ky ban cong bo san pham: 0 san pham.(3) Ghi nhan san pham:Doan thanh tra danh gia ve ghi nhan cua 05 san pham la mau luu tai Cong

ty ghi nhan:^9 9 9

3.1 So san pham duoc kiem tra ve ghi nhan: 05 san pham3.2 So san pham co nhan ghi dung quy dinh: 05 san pham3.3 So san pham co nhan ghi khong dung quy dinh: 0 san pham3.4 So san pham khong co nhan theo quy dinh: 0 san pham Cu the:

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+ Thuc pham bao ve sue khoe vien Bo phe -DNA do Cong ty cong bo duoc Cue An toan thuc pham cap Giay xac nhan cong bo phu hop quy djnh an toan thuc pham so 43198/2017/ATTP-XNCB ngay 20/11/2017. Noi dung ghi

*/• X s\ A \ 9nhan phu hop vbi nhan trong ho so cong bo duoc Cue An toan thuc pham xac

nhan.° m r+ Thuc pham bao ve sue khoe Dai trang hoan -DNA do Cong ty cong bo

duoc Cue An toan thuc pham cap Giay tiep nhan dang ky ban cong bo san pham so 2939/2019/ BKSP ngay 24/5/2019. Noi dung ghi nhan phu hop voi nhan trong ho so cong bo duoc Cue An toan thuc pham xac nhan.

+ Thuc pham bao ve sue khoe Lyzatop do Cong ty cong bo duoc Cue An toan thuc pham cap Giay tiep nhan dang ky ban cong bo san pham so 6595/2018/ DKSP ngay 03/10/2018. Noi dung ghi nhan phu hop voi nhan trong

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ho so cong bo dupe Cue An toan thuc pham xac nhan.+ Thuc pham bao ve sue khoe Xuyen tarn lien DNA do Cong ty cong bo

*A n f % f • f f •> s\ A t Adupe Cue An toan thuc pham cap Giay tiep nhan dang ky ban cong bo san pham s6 7132/2018/ DKSP ngay 01/11/2018. Noi dung ghi nhan phu hop voi nhan

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trong ho so cong bo dupe Cue An toan thuc pham xac nhan.+ Thuc pham bao ve sue khoe Glucose 100 gam do Cong ty cong bo dupe

Cue An toan thuc pMm cap Giay tiep nhan dang ky ban cong bo san pham so 4509/2018/ DKSP ngay 18/7/2018. Noi dung ghi nhan phu hop voi nhan trong

h6 so cong bo dupe Cue An toan thuc pham xac nhan.(4) Dieu kien bao dam an toan thuc phamCong ty dupe Cue An toan thuc pham cap Giay chung nhan co so du dieu

kien ATTP s6: 00510/2018/ATTP-CNDK ngay 27/8/2018 cho san xuat thuc

ph4m. Cong ty CP Dupe - Vat tu y te Nghe An dang trong qua trinh trien khai

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dir an xay dung ca sa dat yeu cdu “thuc hanh san xudt tot” (GMP) thuc pham bao ve sue khoe.

(5) Quang cao san pham:Theo bao cao cua Tong Giam d6c Cong ty, Cong ty co duy nMt website

http://dnapharma.com.vn, tai thoi diem thanh tra website nay khong quang cao san pham thuc pham chuc nang/ thuc phkm bao ve sue khoe (co ban in man hinh tu website http://dnapharma.com.vn kem theo).

(6) Lay man kiem nghiem: Doan thanh tra khong lay mau.6. Cong ty TNHH Dong y An Khanh Tam, dia chi: So nha 27, duong

8, khu do thi Tecco Vinh Tan, phuong Vinh Tan, thanh pho Vinh, tinh Nghe An

Cong bo san pham:Theo bao cao cua Cong ty, tong so san pham thuc phdm chuc nang/thuc

pham bao ve sue khoe do co so cong bo tai Cue An toan thuc phdm: 02 san pham, cac san pham dang ky san xuat tai Cong ty c6 phkn duoc pham Vgas va Cong ty TNHH san xuat dich vu thuong mai Binh An; cac h6 so cong bo con hieu luc. Tai thoi diem thanh tra, Giam doc Cong ty bao cao, kk tu khi cong bo, Cong ty chua san xuat, kinh doanh cac san pham thuc pham bao ve sue khoe da cong bo. Cac san pham Cong ty da cong bo bao gom:

- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe An Khanh

Tam, Giay tiep nhan dang ky ban cong bo san pham so 3172/2019/ DKSP ngay 29/3/2019.

- San pham thuc pham chuc nang/ thuc pham bao ve sue khoe Xixoan An Khanh Tam, Giay tiep nhan dang ky ban cong bo san phdm s6 2596/2019/ DKSP ngay 18/3/2019.

Doan thanh tra ghi nhan tai thoi diem thanh tra tai Cong ty khong co 02 san pham thuc pham bao ve sue khoe neu tren.

7. Cong ty Co Phan Khoa Hoc Xanh Hidumi Pharma, dja chi: Xom 6, Xa Quynh Luong, Huyen Quynh Luu, tinh Nghe An

(1) Ho so’ hanh chinh, phap ly cua co* so’:Giay chung nhan co so du dieu kien ATTP so: 000355/2017/ATTP-

CNDK ngay 08/5/2017 do Cue An toan thuc pham cap cho san xuat thuc pham.t r f

So ngubi lao dong: 20 nguoi. Trong do: True tiep san xuat: 13 nguoi (lam true tiep day chuyen thuc pham); Gian tiep: 07 nguoi

Giay xac nhan kien thuc ve ATTP: 14 nguoiGiay xac nhan du sue khoe cua chu co so va cua nguoi true tiep san xuat,

kinh doanh thuc pham: 20 ngubi(2) Cong bo san pham:Theo Bao cao cua Cong ty, tong so san pham thuc pham chuc nang/thuc

pham bao ve sue khoe co so cong bo: 05 san pham, 05 ho so cong bb con hieu

luc trong do:+ San pham dang san xuat, kinh doanh: 05 san pham + San pham chua san xuat, kinh doanh: 0 san pham

8

X 9 t /V ^ *- So san pham co Giay xac nhan cong bo phu hop quy dinh an toan thirc pham /Giay tiep nhan dang ky ban cong b6 san phlm nhimg da hit hieu lye: 0 san pham.

- So san pham khong co Giay xac nhan cong bo phu hap quy dinh an toan thyc pham/Giay tiep nhan dang ky ban cong b6 san ph4m: 0 san ph4m.

(3) Ghi nhan san pham:Doan thanh tra danh gia ve ghi nhan cua 05 san pham tai Cong ty ghi

3.1 So san pham dirge kiem tra ve ghi nhan: 05 san pham3.2 So san pham co nhan ghi dung quy dinh: 0 san pMm3.3 So san pham co nhan ghi khong dung quy dinh: 05 san phlm Cu the:+ Thyc pham bao ve sue khoe Dau tuong len men Nattokinaza do Cong ty

cong bo dugc Cue An toan thyc pham cap Giay tilp nhan dang ky ban cong bo san pham so 3723/2018/ DKSP ngay 22/6/2018. Noi dung ghi nhan khong phu hop vdi nhan trong ho so cong bo dugc Cue An toan thyc phlm xac nhan ve cong dung, doi tuong su dung, thanh phan, each dung.( NSX:20/12/2018)

+ Thyc pham bao ve sue khoe Ruyu dong trung ha thao do Cong ty cong bo dugc Cue An toan thyc pham cap Giay tiep nhan dang ky ban cong b6 san pham so 2774/2018/ DKSP ngay 22/5/2018. Noi dung ghi nhan khong phu hop voi nhan trong ho sa cong bo dugc Cue An toan thyc pham xac nhan ve cong dung, doi tugng su dung, thanh phan (NSX: 03.05.2019).

+ Thyc pham bao ve sue khoe Tao Spirulina Michio do Cong ty cong b6 dugc Cue An toan thyc pham cap Giay tiep nhan dang ky ban cong bo san phlm so 10168/2018/ DKSP ngay 14/12/2018. Noi dung ghi nhan khong phu hgp voi nhan trong ho so cong bo dugc Cue An toan thyc pham xac nhan ve cong dung, doi tugng su dung, thanh phan, each dung. (NSX: 18.12.2018; HSD: 18.12.2020)

+ Thyc pham bao ve sue khoe Tao Spirulina Michio do Cong ty cong bo dugc Cue An toan thyc pham cap Giay tiep nhan dang ky ban cong bo san pham so so 10169/2018/ DKSP ngay 14/12/2018. Noi dung ghi nhan khong phu hgp voi nhan trong ho so cong bo dugc Cue An toan thyc pham xac nhan ve cong dung, doi tugng su dung, thanh phan, each dung (NSX: 01.03.2019; HSD:01.03.2021)

9 a y ^ A A

+ Thyc pham bao ve sue khoe Bot Dau tuong len men Nattokinaza do Cong ty cong bo dugc Cue An toan thyc pham cap Giay tiep nhan dang ky ban cong bo san pham so 1477/2019/ DKSP ngay 01/02/2019. Noi dung ghi nhan khong phu hgp voi nhan trong ho so cong bo dugc Cue An toan thyc pham xac

* ^ \ r >»aa« #nhan ve cong dung, thanh phan, each dung va thieu “ doi tuong su dung”. (NSX: 01.03.2019; HSD:01.03.2021)

(4) f)ieu kien bao dam an toan thyc phamCong ty dugc Cue An toan thyc pham cap Giay chung nhan co so du dieu

kien ATTP so: 000355/2017/ATTP-CNDK ngay 08/5/2017 do Cue An toan'or r 9

thyc pham cap cho san xuat thyc pham.

nhan:

(5) Quang cao san pham:Theo bao cao cua Tong Giam doc Cong ty, Cong ty co duy nhat website

http://hidumipharma.vn, tai thbi diem thanh tra website nay khong quang cao

san pham thuc pham chuc nang/ thirc pham bao ve sue khoe (co ban in man hinh

tu website http://hidumipharma.vn kem theo).(6) Lay mau kiem nghiem: Doan thanh tra lay 02 mau kiem nghiem, ket

qua kiem nghiem 02/02 mau dat yeu cau (phieu kiem nghiem so

1197; 1198/PNK-VDD ngay 11/7/2019 cua Vien Dinh Duong).

III. KET LUAN:1. Cong ty TNHH Thanh Ngoi, dja chi: Khoi 5, Thi tran Pho Chau,

Huyen Huong son, tinh Ha TTnhTai thoi diem thanh tra, Giam doc Cong ty bao cao Cong ty dang ngung

boat dong san xuat, kinh doanh thuc pham bao ve sue khoe theo Giay xac nhan

cua Phong Dang ky kinh doanh So Ke hoach va Dau tu tinh Ha TTnh xac nhan

ve viec doanh nghiep dang ky tarn ngung boat dong kinh doanh (tu ngay

12/01/2019 den 12/01/2020). Doan thanh tra kiem tra tai Cong ty khong phat hien co san pham thuc pham bao ve sue khoe.

Ve ton tai: Tai thbi diem thanh tra, Cong ty chua co van ban thong bao

gui Cue An toan thuc pham ve viec tarn ngung boat dong san xuat, kinh doanh

san pham thuc pham chuc nang/ thuc pham bao ve sue khoe.Thuc hien yeu cau

cua Doan Thanh tra, ngay 17/6/2019 Cue An toan thuc pham nhan duqc cong

van cua Cong ty (so den 795) ve viec tarn ngung boat dong kinh doanh 12 thang

(tungay 12/01/2019 d<§n 12/01/2020)2. Cong ty co phan Duoc Ha Tinh, dja chi: so 167 dubng Ha Huy Tap,

phuong Nam Ha, Thanh pho Ha Tinh, tinh Ha TTnhCac noi dung co so thuc hien dung:

- Cong ty da thuc hien cong bb phu hop quy dinh an toan thuc pham theo

quy dinh cho cac san pham thuc pham chuc nang/thuc pham bao ve sue khoe do

Cong ty san xuat, kinh doanh. Ho so cong bo cac san pham Cong ty dang kinh

doanh con hieu lire.- Kiem tra 05/05 san pham (mau luu) co nhan ghi dung theo quy dinh.- Dieu kien san xuat, bao quan nguyen lieu, thanh pham: Cong ty co phan

Duoc Ha TTnh dang trong qua trinh hoan thien co so dat yeu cau “thuc hanh san

xuit tbt” (GMP) thirc pham bao ve sue khoe. Ngay 18/5/2019 Cong ty duoc

Doan tham dinh thanh lap theo Quyet dinh so 274/QD-ATTP ngay 23/4/2019

cua Cue An toan thuc pham tham dinh Dieu kien an toan thuc pham dbi vbi co

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sa dat yeu can “thirc hanh san xuk t6t” (GMP) thuc ph4m bao ve sue Idioe. Ngay 01/6/2019 Cong ty da gui Cue An loan thuc pham bao cao kMc phuc vice

trien khai ap dung “thuc hanh san xuk t6t” thuc phdm bao ve sue khoe.Cac hanh vi vi pham, ton tai: khong

3.Cong ty TNHH Thirong mai va cong nghe DKH, tfja chi: So nha

338, Duong Le Viet Thuat, Xa Hung Loc, Thanh pho Vinh, tinh Nghe An.t r

Tai thoi diem thanh tra, Giam doc Cong ty bao cao Cong ty chua san xudt, kinh doanh cac san pham thuc pham bao ve sue khoe tu khi cong b6 san pham. Doan thanh tra kiem tra tai Cong ty khong phat hien co san pham thuc phdm bao

ve sue khoe.Cac hanh vi vi pham, ton tai: khong

4. Cong ty co phan Sata Viet My, dia chi: So 33, duong Luc Nien, Phuong Vinh Tan, Thanh pho Vinh, tinh Nghe AnTai thoi diem thanh tra, Giam doc Cong ty bao cao Cong ty chua san xuat,

kinh doanh cac san pham thuc pham bao ve sue khoe tu khi cong b6 san pham. Doan thanh tra kiem tra tai Cong ty khong phat hien co san pham thuc pham bao

ve sue khoe.Cac hanh vi vi pham, ton tai: khong

5. Cong ty CP Duoc - Vat tu* y te Nghe An, dja chi: So 68, Nguyen Syr

Sach, phuong Hung Phuc, thanh pho Vinh, tinh Nghe AnCac noi dung co so thuc hien dung:

a F 7

- Cong ty da thuc hien cong bo phu hop quy djnh an toan thuc pham theo7 7 7

quy dinh cho cac san pham thuc pham chuc nang/thuc pham bao ve sue khoe do

Cong ty san xuat, kinh doanh. Hien dang san xuat, kinh doanh 13 san pham thuc9 r 7 X /v X \ •pham bao ve sue khoe, ho so cong bo con hieu lire.

- Kiem tra 05/05 san pham (mau luu) co nhan ghi dung theo quy dinh.\ r 7

- Dieu kien san xuat, bao quan nguyen lieu, thanh pham: Cue An toan

thuc pham cap Giay chung nhan co so du dieu kien ATTP so: 00510/2018/ATTP-CNDK ngay 27/8/2018 cho san xuat thuc pham. Cong ty CP

Duoc - Vat tu y te Nghe An dang trong qua trinh trien khai du an xay dung cox r r 7

so dat yeu cau “thuc hanh san xuat tot” (GMP) thuc pham bao ve sue khoe.Cac hanh vi vi pham, ton tai: khong6. Cong ty TNHH Dong y An Khanh Tam, dia chi: So nha 27, duong

8, khu do thi Tecco Vinh Tan, phuong Vinh Tan, thanh pho Vinh, tinhNghe An.

Tai thoi diem thanh tra, Giam doc Cong ty bao cao Cong ty chua san xuat,X X ^ r \ • /s A7 Xkinh doanh cac san pham thuc pham bao ve sue khoe tu khi cong bo san pham.

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Doan thanh tra kiem tra tai Cong ty khong phat hien co san phkm thuc ph^m bao

ve sue khoe.r y • • X •Cac hanh vi vi pham, ton tai: khong

7. Cong ty Co Phan Khoa Hoc Xanh Hidumi Pharma, dja chi: Xom 6, Xa Quynh Luong, Huyen Quynh Lira, tinh Nghe An:

Cac noi dung co so thuc hien dung:- Cong ty da thuc hien cong bo phu hop quy dinh an toan thuc pham theo

? ? t

quy dinh cho cac san pham thuc pham chuc nang/thuc pham bao ve sue l<hoe do

Cong ty san xuat, kinh doanh. Hien dang san xuat, kinh doanh 05 san pham thuc

pham bao ve sue khoe, ho so cong bo con hieu lire.- 02 mau san pham, ket qua kiem nghiem 02/02 mau dat yeu cau (Vien

Dinh Duong ban hanh cong van 383/VDD-KTNN ngay 11/7/2019 ve ket qua

kiem nghiem kem theo 02 phieu kiem nghiem so 1197;1198/PNK-VDD ngay11/7/2019)

• • X •Cac hanh vi vi pham, ton tai:• 9 7.A* -X* '- Kiem tra 05/05 san pham vi pham quy dinh ve noi dung bat buoc tren

nhan hang hoa.

IV. CAC BIEN PHAP XtT LY THEO THAM QUYEN DA AP DUNG1. Cong ty TNHH Thanh Ngoi, dja chi: Khoi 5, Thi tran Pho Chau,

Huyen Huong Son, tinh Ha Tinh.Doan Thanh tra da yeu cau Cong ty co van ban gui Cue An toan thuc

pham ve viec tarn ngung boat dong, Cong ty da chap hanh (ngay 17/6/2019 Cue

An toan thuc pham nhan duoc cong van (so den 795) ciia Cong ty ve viec tarn

ngung boat dong kinh doanh (tu ngay 12/01/2019 den 12/01/2020)).2. Cong ty Co Phan Khoa Hoc Xanh Hidumi Pharma, dja chi: Xom 6,

Xa Quynh Luong, Huyen Quynh Lu*u, tinh Nghe AnDoan thanh tra da yeu cau Cong ty co phan khoa hoc xanh Hidumi

Pharma tarn dung luu thong hang hoa doi voi 05 16 san pham thuc pham bao ve

sue khoe vi pham quy dinh ve noi dung bat buoc tren nhan hang hoa (Dau tuang

len men Nattokinaza NSX:20/12/2018; Rugu dong trung ha thao NSX:03.05.2019; Tao Spirulina Michio NSX:18.12.2018, HSD: 18.12.2020; Tao

Spirulina Michio NSX: 01.03.2019, HSD: 01.03.2021 va Bot Dau tuang len

Nattokinaza NSX:01.03.2019, HSD: 01.03.2021). Ngay 17/6/2019 Cue Anmentoan thuc phdm da ban hanh Thong bao so 1876/TB-ATTP ve tarn dung luu

r 7

thong hang hoa doi voi 05 16 san pham vi pham neu tren.

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V. K3EN NGHICAC BIEN PHAp XlT LY:• •1. Cong ty Co Phan Khoa Hoc Xanh Hidumi Pharma, dja chi: Xom 6,

Xa Quynh Luong, Huyen Quynh Luu, tinh Nghe AnNgay 23/7/2019 Cue An toan thirc pham nhan duac Cong van s6

40/CV/HIDUMI de ngay 15/7/2019 ciia Cong ty co phan khoa hoc xanh Hidumi Pharma de nghi cho tiep tuc luu thong 05 16 san pham neu tren, noi dung cong

van chua neu ro viec Cong ty Co phan l<hoa hoc xanh Hidumi Pharma da hoan

thanh khac phuc nhan cua 05 16 san pham nay va so luong tung san pham dugcr \ '> r

khac phuc ve ghi nhan. Cue An toan thuc pham da co cong van so 2382/ATTP-

PCTTR ngay 26/7/2019 gui Cong ty co phan khoa hoc xanh Hidumi Pharma yeu

cau Cong ty bao cao hoan thanh viec khac phuc ve ghi nhan cua 05 16 san phamr f r t \

neu tren, den thoi diem ban hanh ket luan nay Cong ty Co phan khoa hoc xanh

Hidumi Pharma chua co van ban gui Cue An toan thuc pham ve noi dung tren.Cue An toan thuc pham de nghi Chi cue An toan ve sinh thuc pham tinh

Nghe An giam sat viec khac phuc ve noi dung ghi nhan va xu ly doi voi Cong ty

co phan khoa hoc xanh Hidumi Pharma vi pham quy djnh ve noi dung bat buoc*> 9

tren nhan hang hoa (05 16 san pham thuc pham bao ve sue khoe: Bau tuong len

men Nattokinaza NSX:20/12/2018; Rugu dong trung ha thao NSX: 03.05.2019; Tao Spirulina Michio NSX: 18.12.2018, HSD:18.12.2020; Tao Spirulina Michio

NSX: 01.03.2019, HSD: 01.03.2021 va Bot Bau tuong len men Nattokinaza

NSX:01.03.2019, HSB: 01.03.2021).Sau klii nhan dugc bao cao cua Cong ty co phan khoa hgc xanh Hidumi

r v sy 9 9 /v /vPharma hoan thanh viec khac phuc ve ghi nhan cua 05 16 san pham neu tren datx 9

yeu cau va bao cao cua Chi cue ATVSTP tinh Nghe An, Cue An toan thuc pham

se xem xet ban hanh van ban ve viec hang hoa dugc tiep tuc luu thong theo quy

dinh.2. Cac co* so’ tai tinh Nghe An: Cong ty TNHH Thuong mai va cong

nghe DKH, Cong ty co phan Sata Viet My, Cong ty TNHH Dong y An

Khanh Tam, Theo bao cao cua cac Cong ty nay tai thoi thanh tra, ke tu khi cong b6, cac co so chua san xuat, kinh doanh 16 san pham nao.

9 X 9

Cue An toan thuc pham de nghj Chi cue An toan ve sinh thuc pham tinh

Nghe An tiep tuc giam sat viec san xuat, kinh doanh thuc pham chuc nang/thuc

pham bao ve sue khoe d6i voi 03 co so nay. Truong hgp phat hien vi pham, yeu

c6u xu ly theo dung quy dinh cua phap luat.

13

3. Cong ty TNHH Thanh Ngoi, dja chi: Khoi 5, Thj tran Pho Chau, Huyen Huong Son, tinh Ha TTnh.

Cong ty da dugc So Ke hoach va Dau tu tinh Ha TTnh c&p Giky xac nhan

ve viec doanh nghiep dang ky tam ngimg hoat dong kinh doanh 12 thang (tir

ngay 12/01/2019 d4n 12/01/2020). Ngay 17/6/2019 Cue An toan thuc pham

nhan dugc cong van (so den 795) cua Cong ty vd viec tam ngimg hoat dong kinh

doanh. Cue An toan thuc pham de nghi Chi cue An toan ve sinh thuc phim tinh

Ha TTnh, giam sat hoat dong san xuat, kinh doanh, quang cao thuc pham bao ve

sue khoe doi voi Cong ty nay. Truong hgp phat hien vi pham, yeu chu xu ly

theo dung quy dinh cua phap luat./. ^

Noinhan:- Bo truong (de bao cao);- Thu- truong Truong Quoc Cirong (de bao cao);- Thanh tra Bo Y te (de biet);- Thanh tra So Y te Nghe An, Ha TTnh (de biet);- Chi Cue ATVSTP Nghe An, Ha TTnh (d<§ thuc hien);- Cong ty TNHH Thirong mai va cong nghe DKH, Cong ty co phan Sata Viet My, Cong ty TNHH Dong y An Khanh Tam, Cong ty Co Phan Khoa Hoc Xanh Hidumi Pharma, Cong ty TNHH Thanh Ngoi, Cong ty CP Dirge - Vat tu y te Nghe An, Cong ty co phan Dugc Ha TTnh (de thuc hien);- Website Cue ATTP (de cong khai);- Luu: VT, PCTTR.

eye trltong^tT ' c Jy

ocue

Z an TGAtfV°\THUC PHfi

guyen Thanh Phong

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