FDA report on egg recall company Quality Egg LLC

8/9/2019 FDA report on egg recall company Quality Egg LLC

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOo AND DRUG ADMINISTRATIONDISTRICT OFFICE. ADDRESS AND PHONE FDA Kansas City District Office11630 W 80" StLeno.a,. KS 662143340 (913)7522100

DATE(S) OF INSPECTION&/12/108130/1 0 3006481643.3004793793,3005280357

AND TITlE OF INDMDUAL TO WHOM REPORT IS ISSUED

TO: A. C. d) FET: 3004797952, 3006481709, 3003073159FIRM NAME ,Quality Egg LtC s-meeT ADDRESS2674 Highway 69CITY. STATE ANC liP CODEGalt, Iowa SOlO] TYPE Of INSPECTEDShell Egg Man.umturer AN INSPECTION OF YOUR ARM WE OBSERvED:Tms DOCUMENT LISTS OBSERVAnONS MADE BY TIlE FDA REPRESENTATIVES (S) DURING THEINSPECTION OF YOUR FAC1L1TY. THEY ARE lNSPECTIONAL OBSERVAtIONS, AND DO NOT REPRESENT A.FINAL AGENCY DETERMINATJON REGARDING YOUR COMPLlANCE. IF YOU HAVE AN OBJECTIONREGARDING AN OBSEIlVAnON OR HAVB IMPLEMENTED, OR PLAN TO IMPLEMENT CORRECTIVE ACTIONTN REPONSE TO AN OBSERVAT]ON, YOU MAY DISCUSS TIm OBJECTION OR ACTION WTTH THE FDAREPRESENTATIVE (S) DURING TIlE INSPf-CnON OR SUBMIT TIilS INFORMATTON TO FDA AT THE ADORESSABOVE. IF YOU H.AVB ANY QUESTIONS, PLEASE CONTACT FDA AT THE PHONE NUMBER AND ADDRESSABOVE.pbservations listed below covu ofy-our egg laying farmslplants inspected from 08/l2l2010 through 08/3012010. of Layers 1,3 and 6 included record review and environmental assessments ofaU houses. lnspections of Layers 2 4 i.ncluded record review of allllouses and environmentalassessments for Layer 2 - Houses 7 aud 11 and Layer 4 - House

J7BJ: 3006481643 - Quality Egg LLC, PlantlLayer 1,2615180'" Street, Gatt, TA 50101!FET.: 3004793793 - Wright Co. Egg, PlantlLayu 2, 2550 270Vl Street, Clarion. lA 50525FBI: 3005280357 - Quality Egg LLC, Plan.tlLayer 3,2674 270 ttJ Street, Clarion, JA. fEr: 3004797952 -- Wright Co. Egg, PlanVLayer 4, 2680 250\11 Street, Clarion, lA 50525IFE!: 3006481709 - Quality Egg LLC Environ, Plant/Layer 6. 2865 310 Street., Dows, IA 50071FET.: 3003073] 59 - Quality Egg LtC Feed Mill, 2624 Highwa;y 69, Galt,. IA SO] 01

1. You failed to lUlly illlplement and follow your written SE preventinn plan. ,

a) Your "Quality Egg Bio-security Plan", created On 5/1/10 and updated on 8/11/10, reads in part (Page 8. under section" "), " ", This had not been accomplishedas evidenced by the following Layer 3 - House I 2x6 inch wood board was observed on the ground with apl)foximarely 8frogs living underneath. Layer 3 House 1.5 - unu.''1ed wooden structures were observed located approximately 5 feet from the of the building. Layer 3 - Houses II and 12 - grass 12 inches high was observed in between Houses 11 and 12.

FCR:vl fDA 433 {SlOO) EDITION CDSOlETE U !"'AGE 1or 6

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONDISTRICT OFFICE ADDRESS AND PHONE NUWER DATE(&) OF INSPECnONFDA Kansas City District Office 81t2/10-8130/J 011630 W 80111 St FEINUMBERLenexa, KS 66214-3340 (913) 752 2100 3006481643,3004793793,3005280357NAME AND TJJl.E Of' JNDMOUAl TO WHOM RePORT IS ISSUED10: PEl: 3004797952, 3006431709, J003073 159FN I NAMe STRET ADORI!SSQuality Egg LLC 2674 Highway 69CITY, STATE AND ZIP CODe TYPE OF ESTABlISHMEtn INSPECTEDGalt, Iowa SalOl Shell Egg Manllfaeturer

b) Your "'Quality Egg Bi().security Plan", created on 511110 and updated on 8/11110, reads in pan (page 13, under section" "), ;". Thisbad not beeD accomplished as evidenced by the fo1lowing observations: Nou-dncken feathers wert observed insMe Layer 3 House 3. One live wild bird W88 observed flyingabow chicken caees inside Layer I - House 9. Wild birds were observed flying inside and outsideofLayer 1 HoU9ts 11 and l2. Pigeons were ob,el"\'ed roosting in an air vent where the screening wasdamaged on soum side of the Layer .l - BolJSe 14. Two birds' nests were observed em the o1ltside lltructure of Layer 3 - between Houses] and 2approximately 7 - 12 feet from the manure pit doors. Layer 3 - House 8 had a bird's nest and birds Wcreobserved under the edges of metal siding on the south wall. Chicken m8JI1lre located in the manure pits below the egg laying was observed to beapproximately 4 feet high to 8 fuet hiJh at the fonowing locati.oos: Layer 1 - House 1; Layer 3 - Houses 2,7, 17, and 18. The outside accesll to The manurt pits at these locations had been pushed out by tbeweigbt of the manure, leaving open aceel!lS to wildlife or domegtieated animals. Exterior struetuTal damage allowing entrance to the interior of the laying houses was obsen-ed in Layer 1- Houses 1,3,4,7, R, 11 and 12; Layer 2 - Houses 7 and 11; Layer 3 - Houses 1,2, 11,13, 14,15 and18; Layer 4 - HOllse 3. Observations include: holes in extr;rior siding. missing siding, holes and/or gaps

in the concrete foundation and air vent screens either missing or damaged The east and west doors located on tbe second floOl' egg laying areas of Layer I Houses 1- 14; Layer 2Houses 7 and 11; Layer 3 - Houses 1,3,4, S, 6, 9, 11, 15,16.17, and 18; Layer 4 - Rouse 3 wereobserved to bave gaps at the bottom and sides ranging from a Y.z inch to 2 inches,

c) Your "Quality Egg Bio-seeurity Plan"", created on 5/1/10 and updated on 8/11/10, reads in part (Page 7" under section" "), ". Th;s had not beet1accomplished as evidenced by the following observation: Un-baited, unsealed hole."ii appearing to bt: rodent bunows laeated along the second floor baseboards were

inside Layer 1 - Houses 1 - 9 and 11 \3; Layer. 2 - Houses 7 and 11; Layer 3 -Houses 1,3,4,5, and 6; Layer 4 House 3,d) Your "Quality Egg Bio-SeCUl'Ry Plan", created on 5/1/10 and updattd on 8/11/10, reads in part (Page )2, undersection " "), " )". This had not been accomplisned as evideneed by the following observations:

I:MPLOYEi:(S) SIGNATURESEE REveRSE

OF THISPAGe fJ'S--FORM FDA 483 r81OO) PREVIOUS EDmON OBSOL&TE INSPEC110NAL OBSERVATIONS "AGE 2 6 PAGES

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG AOMINISTAATIONDISTRICT OFFICE ADDRess ANI) PHONE NUMBER DATe(S) OF INSPECTIONFDA Kansas City District Office 8/12/1 011630 W 80'" St FEI NUMElERLenexa, KS 662143340 (913) 752 2100 3006481643,3004793793,3OO52803S7NAME AND T1Tl.E TO WHOM REPORT IS ISSUEDTO: "A. ceo FEI;30041979S2,3006481109,30030131S9FIRM NAME STkEET ADDRESSQuality Egg LLC 2614 Highway 69CITY, STATE AII/O ZIP CODE oP E5TABLISHMENT INSPECTEDGalt, Iowa 50101 Shell Egg Manufaet1J'(er

Dark liquid whicb appeared. 10 be man\D'e was observed seeping through. the concrete foundatioD to the outsideo{tl)e laying houses at the following IOQtions: J..aycr I Houses 1,2,3,4, S. 8, 11, 1.2 and 14; andLa.yer 3 -HoWies I, 8, 13 aDd 17. Standing water approximately 3 incbes deep was observed 8t1h.e southeast comer ofthe man\lJ'C pit lociltCdinside Layer 1 - House 13,

2. YOD faiJect to bke Jtep$ to eIIJDre there itt no introduction or traDJfeT ofSE into or amoug poultry houses. Thil was by the following ob...,rvatioItJ:Specifically,

a) There was only one entry doonvayto access egg 8I'CQ I.oeatod QU. evet7Y other bouse. Entrances for hou5es onLayer I and Layer 2 were located on even numbered houses. Entrances for houses on tayer 3 and Layer 4 were louted on oddpumbered houses. For example, at Layer 3 a-od Layer 4- House 1had. a doorway and tbis same door.way bad to be used to gain!entrance to House 2.b) Employees woOOng within the houses did not wear or change protective clothing wben moving from house to

An employee at Layer 6 - 3 was ob!:'ervcd walking outofHouse 3 with a metal scraper and into House 2 withoutfchanging protective clothing and without cJe8l'ling/saniti:7.ingequipment between the houses.c) Un-caged birds (chickens baving escaped) were observed in the egg laym.g operation .iJI eontact with the egg lay;ng at Layer 3 9 and 16. The birds were using the manure, which was approxlmatcly S feet high, to access

he egg laying aru...d) Layer 3 - House 11, the house entTance door to access both House I) and 12 was blocked with excessive amounts

Iofmanure in the manure pits.

SEE OF THISPAGE

FORM FDA


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DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINI$TRATlONOISTRICT AoDORiSS AND PHONE NUMBERFDA Kansas City District Officel1630 W80 StLenexa, KS 66214-3340 (913) 7522100

DATI($) OF INSPEcno,.8/121) 0-8/30/1 0 3006481643.3004793793,3005280357

NAME; ANDnnE OF INOMDIJAL TO WHOM REPORT IS Issueo

("" -\er fl..1)e CCf.) FEl: 30047979S2, 3006481709. 3003073 I59FIRM NA'MEQuality Egg LLC \ S11lEET ADDIltIiSS2674 Highway 69em , STATE "Ne ZIP cooeGalt, Iowa 50101 lYPE OF ESTABLISHMENT INSPECTEDShe)) Egg ManufacturerJ. You failed to achieve satisfaetory rodent .ad pett control as mdenced by tbe foUowing. a) There were betWeen 2 to 5 live mice observed inside the egg laying as follows:

Layer # IJoase# 'totAl Live Mice ObservedI l 21 5 21 lO 22 11 53 2 43 5 43 7 23 9 23 I t 23 14 34 3 3

b) Live and dead f1i,es too numerous to COWlt were observed at the following locarioruJ inside the laying houses:Layer' - Houses 3,4, 6, 8,9,ll and 12; Layer 2 - 7 and 11,; Layer 3 -Houses 3,4.5,6,7,8, IS, 16, 17 aJld 18. Thelve flies were on and around egg belts, feed, shell eggs and walkways in different sections of each egg layjng llTea. In addition,ive and dead maggots tao numerous to count were observed on the manure pit tloor located in Layer 2 ..,House 7.

Vou did nnt c10eUlllent the monitoring ot rodnts and otlter pest control measures.Specifically, your "Quality Egg Bio-security Plan'" created on 511/10 and updated on 8/l1l10, reads in pan (page 7. under ", bullet 3), "" lnspection of traps and bait stations were not conducted every 7 -14 days as evidenced by:

Layer I did not have doeumented (' ") rodent inspection$ of Houses 1 - 14 after 7/1 SIlO. Layer 2 did not have documented (" ") Todent inspections of Houses 1 and 2; Houses 3 - l4 bad

rodtnt inspections documented for 7n/lO and an additional week that was not dated. The two iml'pections conductedwotlld not adequately cover inspectiolls 14 days &om 7n/lO - 8/12/10. Layer 3 did not have doeumented (" ") rodent i.nspectiom; ofHouses 1 1I atler 7/14/10; Houses12 - 18 after 7/15/1 O.

EMP1.0YltE(S) EEMVERSEOF !'HISPAG/i

FORM FDA 483 (8100) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBseRVATION S PAGE 4 OF 6 PAGES

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND ORUG ADMINISTRATIONDISTRICT PHONE NUMBERFDA Kansas City District Office11630 W 80 th StLeneQ, KS 66214-3340 (913) 752 2100

OATE(S) OF INSPECTION8/12110-8130/10FEINUM8ER3006481643,3004793793,3005280357

OF INDMOUAL TO WtlOM IS ISSUEDTO: h :rAl1,&-k..r\c.ro FEI: 3004797952,3006481709,3003073159FIRM NAME Quality Egg LLC 2674 H;gb,way 69cm, STATE AND ZIP CODE TYPE OF es'TABUStiMENT INSPECTEDGalt, Iowa S010l Shell Egg Manufacturer

Layer 4 did not have documented '') rodent lnspeetiOl1s of HouseII 1, 2, 6, 7, l3 and 16; Houses3 and 4 after 71812010; 10. 11, 12, 14, IS, 17 and )8 after 719120\0. HOlL'ItS S, g, and 9 had, a single week ofrodent inspections doc:umented bllt lite dllte the inspection occurred was not recorded.S. You did not m.intain records comptiance with bioseeurity your "Quality Egg Bio-security P1811", created on SIll) 0 lltId updated on 0811l/1O. reads in part (page 5, undersection ' "). " "

You did not document washing and disinfection of your dead hell trock and manure equipment prior tomoving from farm to !ann. You did not maiJJtain records documenting the washing and disinfection of1he traHers IlStd fur thc movemcntofpullcrs to laying houses under ' ".

You failed to document th,e sip*tare or initials of the person performing the operation ofinspec:ting rodent activity.ogl at the time ill wbich ti c inspection is performed.

Specjfically. review of your " " documencation for Layer 1 - Houses 1 - 14; Layer 2 - Houses 3 - J3;Layer 3 -Houses 1 -18; Layer 4 - Houses 3, 4, S, 6,8,9,10,11,12,14, lS, 17 and 1& did not contain a signature(s)orinitial{s) of he person{s) performing the rodent inspections at tbe time they were pe'lfonned.

7. All required records do not incl.de your n.rne lind the location of your farm.Specifically, your ' " fonn, " ", " " and "" form. for mnnitoring fly lle:tivity. r.odetlt activity and evaluation ofheD hou!le cleaning (respectively) did not containyollt' name. Additionally. some of the " " fonn! and " did not identify the layersite location where the mooitoring occurred

8. On 8114110. tile observation'Were noted at the Quality Egg LLC Feed MlII, loeated at 1614 Rwy 69 Galt, lAS0101 FE): 3003673159Specifieany, Birds were roosting and flying, chicks heard chirping in the scorage and milling facility. In addition, nestingmaterial was observed in the feed mill closed mixing sy!rtem, ingredient storage and truck filling areas.

SEEREveRSEOFTHI$PAGEFORM F04 483 (8100) OBSOLETE INSPECTIONAL OBSERVATIONS 'AGE 5 OF 6 PAGES

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMfNISTRATIONDISTRICT OFFICE AND PHONE NUMBERFDA Kan.sas City District Office11630 W 80111 StLenexa. KS 6621.4-3340 (913) 752 2100

DATE(S) OF INSPECTIOt


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The observations of objectionable conditions and practices listed on thefront of this form are reported:1. Pursuant to section 704(b) of the Federal Food, Drug and Cosmetic

Act, or2. To assist firms inspected in complying with the Acts and regulationsenforcecl by the Food and Drug Administration,

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21USC374(b provides:Upon completion of any such inspection of a factory,warehouse. consulting laboratory, or other establishment. and prior toleaving the premises, the officer or employee making the inspection shaH

give to the owner, operator, or agent in charge a report in writing settingforth any conditions or practices observed by him which, in hisjudgement, indicate that any food. drug, device, or cosmetic in suchestablistlment (1) consists in whole or in part of any filthy. putrid. ordecomposed sUbstance, or (2) has been prepared. packed, or heldunder insanitary conditions Whereby it may have become contaminatedwith filth, or whereby itmay have been rendered injurious to the health. Acopy of such report shall be sent promptly to the Secretary."

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FDA report on egg recall company Quality Egg LLC