SEE REVERSE OF THIS PAGE

FOIIM F1>A 4K3 (llll/tl~)

E'""'LO'\'EE{S) SICHAn!Ro

Raymond M Lam, I nvestigator Christine M Rivera, I nves t i ga t or Erica B Raphael , I nvestigator

X Er""' s R>llhoe1 t.n•b .. ilo:l boot:~f;b:!o Sooed tot too C.lll~lwl -5

PJtEVUlUS EOfOON OBSOlETE INSl'EcnONAL O.BSERVA TIONS

CATEISSUED

9/9/2016

PAGE 1 OF l1 PAGES

DJU'ARTMENT OF HEALTH AND lUJMAN SERVlC.ES FOOD AND DRUG ADMINISTRATION

158- 15 Liber ty Avenue Jamaica, NY 11433 (718} 340- 7000 Ext: 5301 Fax: (7 18} 662- 5661

OAf~(S) 0~ INSPECTICOI

8/15/2016-9/9/2016* FEINW.AeeR

3008734616

Robert J . Schonfeld , President F,f<h!N,t.M~

SM Fish Corp . CIIY, litA11;. ZP CODE. COUNTRY

Far Rockaway , NY 11691-1 138

5001 Roc\away Beach Blvd TYI'EES1ADUSHI.IE>IT II<SPECTE!>

Seaf ood Processor , Manu f acturer , and General Food Manufactur e r ~--~~. ~--------------------------------------~

This document lists observations made by the l;DA reprcsentative(s) during. the inspection of your faciliry. Tiley are inspectional observations, and do not represent a final Agency detennination regardi;1g your compliance. J f you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response t.o 001 observation, you may discuss The objeetion or action with the FDA representative(s) during the inspection or submit this information to FDA al. the address above. lf you hDve any questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSE RVATION 1 You did not implemen t the recordkeeping and verification procedures listed in your HACCP plan.

Specifically during the current inspection on 08/1 5/20 16, 0811 7/20 16, and 09/08i20 16,

A review of your "HACCP PLAN FOR PICKLED HERRING & LOX PRODUCTS," revealed the

following deficiencies:

RECORD KEEPING

• YourHACCP Plan listed ·:(b) (4) ' and' (b) (4) I (b) ( 4) *"as critical control points, with critical limits of a strict fonnulation 'for

each ingredient used, and a monitoring procedure that requjres the{D) (4) I (b) { 4) of the ingredients (or('l) used to be recorded.

However, no "BATCH PROCESS LOG FOR PICKLED HERRING" was available for different

v91rit>:!i ~c;: of Te.::~rlv-to -e:at heTrino nrorln~t<: . nac.h>.rl on . nrodncLtion ilate " fUll /1 f. "

DEPARTMENT OF HEALTH AND HUMAN SERVlCES f OOD AND DRUG ADMlNISTRATION

DISTRICT AODR£S$ AIJS:l PtiONE NUMSEI1 OA TE(S) OF INSPECTION

158- 15 Liberty Avenue 8/15/2016- 9/9/2016* Jamaica, NY 11433 FEI I'It!MBER

(718) 3 40- 7000 Ext:5301 Fax: (7 18 ) 662-5 661 30087 34616

N~ME AND 1'1'ft.e Of INDIVIDUAl 'TO WHOM REFORT ISSI.JED

Robert J . Schonfe l d I President -· F !RMNPJ.IlE STREET AOORESS

SM Fish Cor p. 5001 Rocka~-.~ay Beach Blvd Cln'. STAle. ~IP OODE. COI.INlRY TYPE ESTABLISI11.1EI'<f INSPECTED

Far Rockaway, NY 11691-1138 Seafood Pl-ocessor , Manufacturer, and Gene r a l Food Ma.nufact ur er

EMPLOYEE(Sj SIGHA~~E bAT1; ISSUED

SEE REVERSE Raymond M Lam, I nvest igat:or i i1 WlkHOII:~~ 9/9/201 6 OF THIS PAGE Chris t ine M Riv~ra, I nvestigator X <rb S Folphoel

Erica B Raphael , Invest igator en=&~IINd l.'IWotfO:;I~

~~ ~~t;:t Q. ;tonMtl--6

FORM FD.~ 483 (091081 PREVIOUS ttDJTION OO:O.OLb-rE INSI'ECTJONAL OJ!.<;ERVATlONS PAGE Z Or l Z PAG!;$

VERIFICATION

• Your HACCP plan identified "[(6) (4) " as a critical

control point, which lists a "verification" procedure of ' of(4)- I [ 6) (4) I" and you have not

implemented tllis verification procedure.

• Your HACCP plan jdentified '{(D) (4) I' as a critical control point, which

lists a "verification" procedure of '[(6f(4) I [5) rt) I" and you have not implemented this verification

procedure.

• Your HACCP plan identified i.(6f(4) I r<o) (4 I [(6) (4) I' as critical control points, and lists "verification"

procedures of "calibrate thennometers Koffi) I for aU of the critical control points, and you

have not implemented tbis verification procedure in that your thermometer has not been

calibrated since 06/27/2016.

• Your HACCP plan identified ··~(6) (4) (' as a critical

control point, which lists a "verification" procedure of "calibrate time/temperature recording

DEPARTMENT Of< HEALTH AND HUM.4N SER"1CES FOOD AND DRUG ADMINJSTRATION

OIS""'ICT ADDReSS AND PHONE NUMBER ----,O~A~=~~c~O~FI~m~PE~C~TKm~~-----------------------~

158- 1 5 Libert y Avenue Jamaica, NY 11433 (718) 340- 7000 Ext : 5301 Fax : ( 718) 662 - 5661

8/15/2016- 9/9/2016* FEINUMBER

3 008 7 34616

~NA,.,-.M;,-E-;-;AN"D"'TIT""LE;=-;Of=oN""DIV""IO'-'VT."AI.Y.TO"w""H""OIII~R""EP"-'CR'"'T,-;;ISS""u'"'-e"'D----------------·--------~------------------------------------J

Rober t J. Schonfeld , Pr esiden t FIRM NI\ME STREET ADDRESS

SM Fi s h Cor p . 5001 Rockaway Beach Blvd hcr""TY". S""TA""TE,-."'ZIP"'C""O"-'DE", co"'u""N"'TR""'Y-----------------·- -- - - ---+-,;:1YPEIOSTA8LISHMENT INSPECT"'ED;,.-------------- --------------J

Fa r Rockaway, NY 1 1691- 1138 Seafood Processor , Manufacturer, a n d General Food Manufac turer

-----------~------

devices and thermometers[(or(4} f and you have not implemented this verification procedure in

that your thermometer has not been calibrated since 06/27/2016.

---------------------------------·- ----------------------------------------------OBSERVATION 2 You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.

Specifically,

Upon initiation of the inspection on 08/15/2016, it was determined that your firm processes the

following seafood items and your firm did not have a completed and signed HACCP plan in place to

control for hazards (including but not limited to physical - metal inclusion, and chemical - allergen) that

are reasonably likely to occur.

Frozen/to be cooked:

(b) (4)

Ready-to-Eat:

SEE REVERSE OF THIS PAGE

EIIIPLO\'EE(S) SIGNATURE

Raymond M Lam, Investig~tor

Christ i ne M Rivera, I n vest igat o r Erica 8 Raphael, Invest i gator

X & lc:oaRa¢loel

J!W~

~~'e<r:~S. P.Io:Nci..s-

FORM FDA 483 (~9/08) PR!:.'VfOUS EDrrJON OUS.OLE1E lNSPECTIONAL OBSERVATIONS

DATt: ISSLI£0

.9 / 9 /2 01 6

l'AGE 3 0l' l2 J'AGES

DEPARTME!'.'T OF HEALTH AND RUMAN SERVICES FOOD AND DRUG ADMl.NlSTRATlON

OISTRICT APD!<fSS AND PH ONE NUMBER

158- 15 Liberty Avenue J ama i ca, NY 114 33 {7 1 8) 340- 700 0 Ex t : 5 30l Fax : (718 }662-5661

NAME AND Tlli....E Oj: INPIVIDUA~ 'J'O WHOM REPORT ISSU S:O

Robe r t J . Schonfeld , President F!RM NAME -

SM Fish Cor p. CITY, SiAn:,. ZIP C0ll~, COUN1'RV

8/15/2016- 9/9/201 6 * FEI NUPABER

3008734616

5001 Rockaway Beach Bl vd TYPE ESTABUSHMENT INSPECTED

Far Rockaway, NY 11691-1138 Seafood Processor, Manufact urer , and General Food Manuf acture r

SEE REVERSE OF THIS PAGE

FORM FIH ~33 (~~lOS)

EMPL.O'I'EE(S} S!G>I~ TUllE

Raymond M Lam, Inves t igator Chri s tine M Ri vera , I nves tiga t or Eri ca B Raphae l , Inves t igator

X f rico 6 Ravhael

bR~UJI

~br: fJ~:;~ aa..p~>;.o,t.s

PREVTOUS EOIDON ORS.OlErE INSJ'ECTIONAL o ·BSERV A'nONS

0.-'< 1E ISSUED

9/9/2016

PAGE 4 OF 12PAGES

OBSERVATION 3 Your process monitoring equipment is not calibrated to ensure that it reads accurately.

Specifically on 08/17/2016, and 09/08/2016,

• The digital reading on the walk-in refii gerator( b) ( 4) was no ~~~~-----------------------J

less than 6 degrees Fahrenheit higher than what the device was recording on the temperature

chart.

OBSERVATION 4 You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food . . .

DEPARTMENT OF HEALTH AND HUMAN SEnVICES FOOD AND DRUG ADMlNISJRATION

. -- DAT£(S)OFiii'""SP""'Ec""T""toN~-----------I

158-15 Libe rty Avenue Jamaica, NY 11~33 (7 18) 340- 7000 Ext:5301 Fax : (7 18 )662-5661

NAM!: AND TrTLE Of JNOIVIOUAL TO WHOM REPORT ISSUED

Robert J . Schonf eld , President

8/15/20 16- 9/9/2016+ FEi fJUMilER

3008734616

~ •• ~~~UAA~~--------------------------~r=s~~~A=o~~~-------------------------

SM Fish Corp : 5001 Rockaway Beach Blvd CITY, ST .. TE, ZIP CODE. COUNtRY TYPE ESTABLIS-I"T IIIS?ECTEJ.)

Far Rockaway, NY 11691-1138 Seafood Processor, Manufact urer, and General Food Manufacturer

~----------------------~~~~~ ~~~~~~---------1

r------------.--------------------------------------------------·---------,--------------;

SEE REVERSE OF THIS PAGE

E>IPLOYEE(S} SIGioiATURE bAl'2 ISSUED

9/9/2016 Raymond M Lam, Investigator Chri s t ine M Rivera , Investigator Erica B Raphael, lnvest igat or

)r,.~u~

~-----------~---------------------------------------------~-~==~~~-~~··~·-~-~·----~------------f

fiORM FllA 48; (~108) f'RF.VlOUS IDJTION OllSOLE'IE INSPECflOI\'AL OBSERVATIONS PAGE 5 OF t lJ>AGES

Specifically during the current inspection on 08/15/2016, 08117/2016, and 09/08/2016, it was revealed that:

You are not monitoring for the condition and cleanliness of food contact surfaces as evidence by:

• On 08/15/206, 08/17/2016, and 09/08/2016, the inside panel ofthe[(b) (4) I door (above ready­to-eat ice) on the ice machine was observed with exposed and cracking foam insulation; pieces of insulation were missing.

• On 08/15/2016, 08/17/2016, and 09/08/2016, the metal guard on the[(o) (<4) lin the raw fish processing room was observed to be broken with missing metal pieces.

• On 08/17/2016, after cutting boards used in the raw fish cutting room were cleaned, they were

subsequently re~ted on surfaces that were not cleaned and sanitized.

You are not monitoting for the prevention of cross-contamin51tion from insanitary objects as evidenced by:

• On 08115/2016 and 08117/2016, and 09/08/2016, an accumulation ofpooled liquid was noted on the floor under and[( D) (4 )]of the ice machine located[(o) (:1:1. )]the doors leading to the~5f{4n [(of(4) I

• On 08/15/2016 the drain line of the wash sink in the herring room was noted to be draining directly onto a metal cover for a grease trap, as well as the[(o) -(4) ] ioom floor.

• On 08115/2016 the wash sink in the herring room has a crack in it that is separating the wash sink from the backsplash.

J)El'ARTMENT OF l:l."EALTH AND HUMAN SERVICES !··.:

FOOD AND DRUG ADM!NlSTRA TION I'JIST'RlCl AOORESS ANO PHONE NUMBER: 0AT£(S}OF INSP£CTtof~

158- 15 Li berty Avenue 8/15/2016- 9/9/2016* Jamaica , NY 11 433 FEI NUME<5R

(718 ) 3 40 - 7000 Ext : 5 301 Fax : (718 ) 662- 5661 3008734616

NAME AND TITI..E. OF INOIVJDUAl TO V'MO>.l REPORT ISSUED

Robert J. Schonf eld f President FIRM NAME STREET ADDRESS

SM Fis n Co:t:"p . 5001 Ro c kawa y Beach Blvd C!lY. STATO., ZJ~ CODE, CO'J NT!tY TY!'E E.STA8LIS"""EI~T INS~CTEO

Far Roc kaway, NY 11691 - 1138 Seafood Processor, Manuf a c ture r , a nd Gener al Food Manufacturer

You are not monitoring for the exclusion of pests as evidence by:

• On 08/15/2016 an apparent dead insect was noticed in the walk~in refrigerator .

O BSERVATION 5 You did not review some of your critical ~ontrol point monitoring records within one week after the records were made.

Specifically, during the inspection on08/15/2016, 08/17/2016, and 09/08/2016,

• A review of your "RECEIVING LOG" for the receipt of raw, refrigerated and frozen fish

revealed that these records were not reviewed [(5} (LI.} I after the records were made for

the following dates:

o [(o) (4) I "

• A review of your "RECEIVING LOG" for the receipt of raw, refrigerated and frozen fish

revealed that these records was not signed and dated as "reviewed" for the following dates:

0 (b) (4) • A review of your [(5) (4 )---,ANITA TION LOG" fron (o) (4) had no entries for

the week when we checked the paperwork on 08117/2016. The review of the "DAILY

SANITATION LOG" there are no records between1(5) (4} I

I

• A revjew of your {(o) (4)J SANITATION LOG" fron1(§ [ (1) !revealed that this recoru was not s1gneu anu uateu as revJeweu. ·

• A review of your l(O) (4)1PACKAGING and LABEL MONITORING LOG" for the follovving

EMPLOYEE!S) SIGNATURE DATE ISSUED

SEE REVERSE Raymond M Lam, In vestigator {;:; t ........ ~~l>" .... - 9 / 9/201 6 OF THIS PAGE Chris t ine M Rivera, I mrest iga tor X er1co s Ravh••'

Erica B Raphael, Inve st i gator &-llbpt .. of

(lw~ll!l

~b,':l!tU& IO:~d~

f'ORM l"!l.A 4Sl (0,/1)3) PREVJOUS l'DfllON OBSOLEtE CNSPECTIONAL OBSERVATIONS PAGE 6 OF l2 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMLNISTRATJON

DISTRICT ADORE..C:.S AND PHONE NUMBER I OATE(S) OF iNSPECTION

158- 15 Liber ty Avenue I 8/15/201 6-9/9/20 1 6* J ama ica, NY 11433 FEINUUBER :

(718) 340-7000 Ext : 5301 Fax : (718)662- 5661 3008 '734 616 :

N~ME Afl.ltl Trrt.E o;: INOiV10UAL TO Wl-(0~ R'EPORT tSSUEO

Robert J . Schonfeld , Pr es i dent FIRM NAME STREt;r AOORJ;SS

SN Fish Cor p . 5001 Rocka~1ay Beach Blvd Cff'Y, STATe, ZIP COD~. CO<.JNl f!Y 1YPE ESTABUS!-IMENT INSPECTED

Far Rockaway, NY 11691-1138 Seafood Processor, Manufacturer, and General Food. Manufacturer

EMPLOYEE(S) SIGI'IATUR!; DA~ ISSUED

SEE REVERSE Raymond M Laro, Investigator r-~- 9/9/201 6 OF THIS PAGE Chri s tine M Ri ve r a, I nvestigator X EOO B Raphael

Erica B Raphael, Investigator t..,,-.,1"' ... 1 ·--~fold-bf ~lll:~l.lo~;..l~

FORM ffiA 4&3 {09/0S) PR:E.\IIOUS EDmON OBSOLETE l"'SJ>ECTIONAL OBSERV A'llONS PAGE 7 Of' 12 PACffiS

products, revealed that these products were not signed and dated as "reviewed":

0 on[(l5) (4) ~forl(on~r I

0 On[ l5) (4 ) ~for[(o) (4) I 0 On~5f(4)lfor0Ct5f{~) I

0 On[{o) {4) I for (6)(4) I [(~)j4) J as well as[(of(4) I products.

0 On:{~)- (4) Jfor i(D) (4) I [(6) (4) I

0 oq(~)_(~for [(o) (4) I '

• A review of your "BATCH PROCESS LOG FOR P1 CKLED HERRING" does not always state

the date the process took place. ThJ(6) (4) I and0C6) (4) ;vere not

always listed for the products.

• A review of your ''BATCH PROCESS LOG FOR PICKLED HERRING" that expires 08/04 states it was reviewed by '(b) (6)\' on "08/20" a date had not occurred during review of the

documents on 08/17/2016.

• A review of your temperature recorder charts for the walk-in refrigerator revealed that record had

recorded more than one week based on the number of lines on the chart. The da:te listed on the

recorder chart was only from[( c) (4) I • A review of the temperature recorded charts for the walk-in refrigerator revealed only two

records[(o f(4Y There were no records for July

JH~PA.llTMENI Of"ll.EALTH AND HUf>L\N SERVICES FOOD AND DRUG ADMJNlSTRATlON

DISTRICT ADDRESS AND PHONE NUMSER DA TE(S) OF INSPECTlON

158- 15 Libe r ty Avenue 8/15/2016-9/9/2016* Jamaica, NY 11433 fEINUMS~R

(718) 340-7 000 Ext: 5301 Fax: (7 18)662- 5661 30087 3461 6

f-NAME AND Tm..E OF INDIVIDUAL TO lM-101.< REPORT ISSUED

Robert . J . Schonfeld I Pres i de nt FIRMNI\ME STREET ADDRESS

SM Fi s h. Corp. 500 1 Rocka\vay Beach Blvd '-CITY. STATE. ZIPCOOE. COUNTRY TYPE ESTASLISHMEWT INSPECTED

Fa r Rockaway, NY 11691 - 1138 Seafood Processor, Manufacturer, and Genera l Food Manufacture r

!:MPLOYEE(S} S !GAA TURE DATE ISSUED

SEE REVERSE Raymond M Lam, Inves t igator ~ ~rw.w • .,....w ... 9/9/2016 OF THIS PAGE Chris t ine M Ri vera, Investigator X Erici>SI'<oilhae

Erica B Raphael, I nves t igator &-II !to""'"~' \l,.~l:lol

~m:C:lf: ti~I~..S

WRJI! FDA 453 (09ill81 E'R.EVlOUS EU11'10N 00!;0l...Et1! INSPECTIONAL OBSl':RVATlONS PAGE 8 OF 12 PAGES

since our last inspection.

• A review of the temperature recorded charts for the walk-in refrigerator revealed that for the records from[(or(4) I they were not signed and dated as reviewed.

• A review of your "Thermometer Calibration Log For Cooler" for this year has not been calibrated or reviewed after~ D) -(~) I

OBSERVATION 6 Lack of effective hand cleaning preparations.

Specifically,

• On 08/15/2016, there was no soap in the handwashing sink located in the ready-to-eat kitchen .

-· OBSERVATION 7 Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces.

Specifically,

• On 08/15/2016 and 08!17/2016, employees were observed to clean equipment and utensils

including knives, cutting boards and colanders by scrubbing them with soapy mixture and

subsequently spraying them with a pressurized hose, but without a subsequent sanitizing step

DEPARTMENT OF lU:i\J,'flJ 1\l'.'J> lf(JMAN SERVICES FOOD liND DRUG Al)MINJSTRA TION

OISTR!CT ADDRESS AND PHONE NUf.4BER DATE(S) OF INSPECTION

15 8-1 5 Liberty Avenue 8/1 5/2016-9 /9/2Q}6Y Jamaica , NY 1143 3 FEII'IVMllER

(718} 3 40 - 7000 Ext :53 01 Fax : (7 18 ) 662 - 566 1 3008734 61 6

NAME AND TITLE OF INOIVIOUAL TO WriOM REPORT ISSUED

Robe r t J. Schonfel d , Pres i dent FIR~ NAME STREET ADDRESS

SM Fish Cor p . 5001 Rockawa y Beach Blvd CITY, STATE. ZIP COOS. COUNTRY TYP!'. ~STA8USHM£NT INSPECTED

Far Rockaway, NY 11 691-1138 Seafood Processor, Manufact urer , and Gene r a l Food Manu f acture r

--BIPl.O'<EE(S) SIGNATURE DATE fSSLfSO

SEE REVERSE Raymond M Lam, I nve s t igator C b~lo:.s.;~m~t.. .. ~ 9 / 9/20 16 OF THIS PAGE I Christi ne H Rivera , Invest igator X !:n:a B Ril!>hael

f.Jb 8h!*;iitel Erica B Raphael, Investigator .., .. ~,.,.. Slf~~·: r:u "II.•F....,.! Ji.

FOR....,: J'l)A 4&~ (09/ll&) PREVIOUS F.DIDO:N OBSOLET.E l:NSPECTIONAL OBSER\' A TIONS PAGE 9 OF 12 PAGES

prior to using them for food preparation or placing them on a drying rack.

OBSERVATION 8 Failure to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing.

Specit1cally,

• On 0811 5/2016, the cheese slicer in the cheese processing room was observed to have debris

located on its surface. Room was cleaned at the end of the previous shift, and has not been used

on that day.

• on 08/15/2016, the[(6r(4) I was observed to have debris still in th~(b} ( 4 )J mechanism.

[(6) (~) lwas stored on a milk crate in the comer of the Prepared Food Kitchen.

• On 0811 5/2016, flying insects were noticed landing on the cutting board and knife used in the

Prepared Food Kitchen area:

• On 08/15/2016, food debris was observed in the cutting mechanism and around the contents of

th0,(6) (~) lis stored on the drying rack next to the Prepared

Food Kitchen three compartment sink.

OBSERVATION 9

DEPARTMENT OFIIEALTH AND HUMAN Sl:RVlCl'.S FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS~ PHONE NUMBER DA TE(S) Of INSPECTION

158- 15 Liberty Avenue 8 / 1 5 /2 01 6- 9/9/2016* Jamaica, NY 11433 FEI NUJJBER

(718) 340-7000 Ext: 530 1 Fax : (718 )662-5661 3008734616

~-.1\00 TITLE OF INDIVIDUAL TO 1M<OM REPORT <SSUED

Rober t J . Schonfeld , Presiden t FIRM NAA~E STREET ADDRESS

SM Fish Corp . 5001 Rockaway Beach Blvd CITY, STATIO. ZJPCOOE. COUNTRY

-TYPE ESTABiJS~NT INSPECTED

Far Rockaway, NY 11691-1138 Seafood Processor , Manufact u rer , and General Food Manufacturer

EMPl OYEC(S) SIGNATl.JRE OATFISSU:O

SEE REVERSE Ra:r'Tilond tv! Lam, I nvest i gator C,: lf'l'l! IQ~"l•·Y;;rt 9/9/20 1 6 OF THIS PAGE Chris t ine M Ri ver a, I nves t i g a t or X Eri12 g R3pn:;d

Erica B Raphael, Inve s t i ga t or lr'G»~J)Io~

ln •t~lcn

~21:Enc~S.~t1.!.

FORM FDA 483 (0?/RS) PkEV'IOUS EDmON OBSOLETE msr•ECTIONAL OBSERV A TfONS l'AGE 10 01'12 PA\£S

~ Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

Specifically,

• On 08/15/2016, flying insects were noticed landing on the cutting board and knife used in the

kitchen area.

OBSERVATION 10 Failure to handle and maintain equipment, containers and utensils used to hold and store food in a manner that protects against contamination.

Specifically,

• 08/ 15/2016, in the kitchen area, hard boiled eggs were being broken apart in a large mixing bowl

resting on a garbage can.

---- -OBSERVATION 11 Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.

Specifically, during tl1e walk-through on 08/15/2016,08117/2016, and 09/08/2016

• The bottom comer ofthe[(D) (4) I of the entrance, into the[ D) (4) Jroom

had missing tiles, cracked tiles, and the wood molding was broken. There was also a gap

between the wall and the broken wood molding.

SEE REVERSE OF THIS PAGE

FORM PI><' 4Sl (~?/118) PAGES

E .... PLO)'E:E(SJ Slf'~TU~

Raymond M Lam, Inves tigator Christine t~ Rivera, Investigator Eri ca B Raphael , I nvest i gator

X E<i"' a Raphael f.roll~tiiote~ ,.~$.·

Ss.U"'. trt;,e lle~l-5>

PJIE\'Jous SDmoN oesor.:<.n: INSl'ECriONAl. OBSERVATIONS

DATE ISSUED

9/9/2016

PAGE II OF 12

DEPARTMENT OF HEALTH AND IDJM.4.N SERVICES FOOD AND DRUG AD:MJNTSTRATION

OtSTRICT ADDRESS AND PHONE NUMBER

158- 15 Libert y Avenue Jamai ca, NY 11 433 (7 18 ) 340- 7000 Ext : 5301 Fax : {7 1 8)662- 5661

NAME AND 71T\..E OF INO<VIDUAk TO 1MiOM REPORT ISSueD,

Robert J. Schonfeld , President

Sl"J f i sh Corp . CITY, STA1E, Z!PCOOE, COUNTRY

DATE(S) OF INS'E<:TION

8/15/2016-9/9/2016* FEINI.lMSER

300873461 6

~EET AODRESS

5001 Rocka1~ay Beach Bl vd TYPE ESTASUSHMENT INSPECTED

Far Rockaway , NY 11691- 1138 Seafood Pr ocessor, Manufacturer, and Gener a l Food Manufacturer

· • The floor around the[ .... ~(o--'-) -'(-~.:..) ___ __,lin the corner of the herring preparation area was noted to

be uneven allowing debris to collect in this location.

• The tloor in thd(b) ( 4 )]of the herring preparation room, near the floor drain and the meta1 floor

panel was noted with gaps allowing liquid and debris to pool in this area

• The floor in the entry way to the herring preparation area was noted with cracked and uneven

concrete. In addition, the cement surfaces where the floor met the walls in this area were

cracked and missing pjeces.

• The concrete floor surfaces and the walls at the floor-wallj tmction in the entry to the raw fish

processing room were noted to be uneven and cracked allowing liquid to pool.

• The concrete floors throughout the raw fish processing room were pitted allowing liquid to pool

on the floor surfaces.

Specifically, during the walk-through on 08/15/2016,

• The Air Conditioning unit in the cheese processing room was observed with liquid leaking onto

the food preparation surfaces below.

DEPARTMENT OF HEALTH AND HLMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

158-15 Liberty Avenue 8/15/2016-9/9/2016* Jamaica, NY 11433 FEI NUMBER

(718) 340-7000 Ext:5301 Fax: (718) 662-5661 3008734616

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED

Robert J. Schonfeld '

President FIRM NAME STREET ADDRESS

SM Fish Corp. 5001 Rockaway Beach Blvd CITY, STATE, ZIP CODE, COUNTRY TYPE ESTABLISHMENT INSPECTED

Far Rockaway, NY 11691-1138 Seafood Processor, Manufacturer, and General Food Manufacturer

Q Invalid signature I;J Invalid sjgn~ture

X Christine M Rivera X Raymond M Lam Christine M Rivera Rilyrmnd Mlilm

Invest 'gator Invesi:~Jator

SO;Jned by: Christine M. Rivera -S Si;Jned by: RaymJnd L>lm-S

c '""'"''~"''""

X Eric;o El Raphael EhcaBRa""'<l

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*DATES OF INSPECTION 8/15/20 16(Mon),8/17/2016(Wed),9/08/2016(Thu),9/09/2016(Fri)

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE

Raymond M Lam, Investigator Christine M Rivera, Investigator Erica B Raphael, Investigator

DATE ISSUED

9/9/2016

FORM FDA 483 (09108) PREVIOUS EDmON OBSOLETE L'ISPECTIO!>AL OBSERVATIONS PAGE 12 OF 12 PAGES

The observations of objectionable conditions and practices listed on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or

2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides:

"Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."