e t,IJ>LOYEE(S) SIGNATURE DAl E ISSUED

SEE REVERSE Andre~1 M Kupper, Investigator I X A<>Jre:1 N Kupper

1/1\'nl1 3/15/2017 OF THIS PAGE Kenne th E Felkley, Investiga t or

Mary B Sheets, Investigat or l '"-"'""";,....,.,.')',, ~":'d t>t: ~~e-.ft;..,:::;ws·!

FORM FDA ~SJ (G9103t PREV10~$ EDmO~ OBSOI.f.TE JNSl'ECTJONt\L OllSEHVATIONS PAGe l OF 7 PAGES

·DEPAH.HlEi'ff OF HEALTH AND HUMAN SERVICES FOOD AND DRUG AD:'.UNISTRATION

DISTRICT ADDRESS AM> PHm.'E 1.'\,"·' Bffi

6751 Steger Dr i ve Cincinnati , OH 45237 - 3097 (513)679 -2700 Fax : (5 13 ) 679- 2772

OATE(Sl Cf' 111SPECTJO:I

3/3/2017-3/15/2017* fiil NV~~aeR

1022121

NAl.~EAJ..'O Tm..E OF INOMOUAl TO \MiC!'.t REPORT ISSUED

Rober t C. Carl I Pres i dent

J

FIRM NAME STReETAOORo$$

Dixie De1-1 Product s Inc 1360 Jamike Ave, PO Box 18310 CrrY. STATe', Z•PCOOE. COliNTRV iYPEE.STABUSHI,.\.ENT IHSPECf£0

Erlanger, KY 410 18-3114 Manufact urer

This document lists observations made by the FDA representativc(s) during the inspection of]•our facility. They are inspectionat' observations, and do not r~present a final Agency determination regarding your compliance. If you have an objection regarding an observation, orhave.implemented, or plan to implement, corrective a~tion in response 10 an observation, you may discuss the objection or action with theFDA rcprcscntativc(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1 ;

Failure to manufacture and package foods under conditions and controls necessary to minimize the potential fo r growth of microorganisms and contamination.

Specifically,

A. Your firm does not conduct a kill step for SoyNut Butter product remaining in your f irm's mixing kettle

leftover f rom a productio n run. Your Plant Manager stated, up toRIJ) (4); may rema in in the kettle

overnight or weekend prior to resuming production. You and your Plant Manager stated the ~I:)) (41

I ! the kettle is shut off when product rema ins in the kettle overnight and/or over the weekend.

B. According to your Plant Manager and Maintenance Supervisor, yourRil> (4} machine, used for f ine

m ixing of the SoyNut Butter and OCo) (:it) t, rout inely shuts off during processing. Your

Plant M anager stated t his occurs 1-2 times per day and, this pro blem has persisted for approximately 15

years despite repeat ed maintenance intended to correct the problem.

c . Your firm moni tors the SoyNut Butter ~ll} (4} 1with an [ b} (':l0 thermometer. Your Plant

Manager stated he has never verified t he accuracy of th is instrument.

D. According to you and your Plant Manager, your tem perature probe and chart recorder, initially

engineered to verify and record fo) (4) J of product in t he large mixing kettle, j s not

functio ning properly and has not been used for well over a year.

E. During production of I.M. Healthy SoyNut Butter Creamy cups, Lot 065171 on 3/6/2017, a dear liquid

E.MPI.OYEE(S) SlGNA'CUAE

SEE REVERSE Andre1·1 t--1 Kupper , Investigator OF THIS PAGE Kenne t h f. Felkl ey, Investigator

Mary B Shee t s, Investigator

DAlE ISSUEO

3/15/2917

.._~,.,l'l r"'~

...~,.,., !~'r'(k~•KI_;If:;<4' •l

FORM FDA ISJ (m,os. HlEVfOCS EotTIO~OOSCA.ETE · INSPl\CTlONAL ODSEUVATIONS PAGF. 2 OF 71'.\GES

~-------------------·-----------------------------------------------------~

T>F:PARTIIEi\'T OF HEALTH AND Hlfi\IAN Sl!:ltVlCES FOOD AND DRUG ADMINISTRATION

D ISTR ICT ADDRESS At.:O PHO~:E h'UJ,ISER

6751 Steger Drive Cincinna t i , OH 45237 - 3097 (5 13) 679-2700 Fax: (513) 679-2772

IIA'lE; AND TmE; Cf l lwtVIOUM. TO lf,\10!.1 REI'()RT ISSUED

Robert C. Carl , Pr esident FIRM NAM£

Di xie Dew Product s I nc CllY. S TATE.ZIP CODE, COVNTRY

Er l anger , KY 41018-3114

OATE!S) OF INSPECTION

3/3/2017-3/15/2017* Fcii<UMSER

102212 1

STREETA06fl'O<eCFss;c------------ --- ---J

1360 Jamike Ave, PO Box 18310 TYPE ESTAJlLISH.,.EilTIII!'I'ECTEO

~lanufac turer

substance was observed dripping intermittently from a hole in a ceiling tile in your firm's Soy Butter

Processing Room· and landing on the Processing Room floor and splashing on food manufacturing

equipment below. The dripping liquid persisted throughout the duration of the pwduction run which

spanned from approximately [(o}'(4}' 1- According to you, the liquid was w ater from a leaking b

pipe which runs above t he ceiling tiles.

F . The floors, walls, and ceilings in the Soy Butter Processing and Packaging Rooms are heavily coated with

apparent old SoyNut Butter build-up from previous production runs. Additionally, standing water and

brown and black apparent filth w as o bserved on the Processing Room f loor; particularly under

equipment in hard to reach pl aces and along the floor/wall junctures. Employee w alking platforms used

to access equipment during production were also observed to have a heavy coating of apparent old food

residue and filth.

OBSERVATION2 All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.

Specifically,

A. Your f irm does not have any employee or equipment traffic controls throughout the diffe rent operation

areas of your firm, o r between the facility and outdoors. Employees were observed w alking throughout

all areas of the facility including inside the boiler room, the exterior of the facility, bathrooms, and other

areas outsid e the firm's different processing rooms. These same employees later walked into the Soy

Butter Processing and Packaging Rooms without any controls in place to minimize cross-contamination

of the different areas of the facil it ies. Additionally, your firm has (15) mechanical forklifts, which operate

t hroughou t the interior facilit ies and outside the facility for wast e disposal. These forklifts were

DEPARTMEi\T OF HEALTH AND H~I,\N SERVICJ::S FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS A~O FHO~.'E IOV!/ BER

675 1 S tege r Dr i v e Ci ncinnati , OH 45237-3097 (5 13)67 9 - 2700 Fax : {513)67 9- 2 772

PlA1.'E Atm Tlll..E CA= INOMOUAL TO V.~OM REPORT ~SSt.JEO

Robe r t C. Carl , Pres i dent FlRM NA'J.E

Di xie Dew Products Inc CITY. S f ATE, Z•P COOe, COUNTRY

Erlange r , KY 410 18-31 14

STREET ADORE$$

1 360 J ami ke Ave , PO Box 1 8310

Manufac tur e r

DATE(S) OF IIISPECTIOil

3/3 / 2 0 17 - 3/1 5/201 7* FEI I:VMSER

1022121

EJ.IPI.O""E(S) S IGI.!J\TlJI\E

SEE REVERSE Andre1·1 M Kupper , I n vest i gator OF THIS PAGE Kenne t h E Felkl e y, I nvest i gator

Mary B Sheets, Inves t igator

DAlE ISSUED

3/15/2017

"-"-'-"' ' :.;or;« 1':'~-:ll

$~i ""' 'Y kQ- H. t~a..-$

..0&\t FDA l8J (0911l&) PRH10USEDmONO!!SOI..F.TE lNSI'EC'I'IONAL OBSERVATIONS PAGE 3 OF 1 P,\<JES

~--------------------------------------------------------------~~w~ ~~Ln

observed moving in and out of your Soy Butter Processing and Packaging Rooms. On 3/13/2017, a green

,forklift was used to move processing waste from inside the facility to the firm's waste dumpster located·

outside. The Plant Manager stated these forklifts are never cleaned.

,. _

B. On 3/8/2017, your cleaning supply cabinet was observed in disarray. Bathroom cleaning mops, brooms,

and other cleaning equipment were intermingled and in contact with similar cleaning equiprl)ent used to

dean manufacturing equipment in processing rooms. The mop heads, brooms, brushes and other

clea ning tools were in poor repair and covered in apparent old food residue. Many of the mop and

broom heads were stained black from apparent filth.

G . The interior of the (15) (4) J bulk soy oil tote your firm used to manufacture the I.M. Healthy SoyNut

Butter Creamy cups, lot 065171 on 3/ 6/2017, was observed soiled with brown apparent residue.

According to your Plant Manager, these totes are never cleaned. Additionally, the top port lid to the tote

remained opened during the manufacturing and cleaning process on 3/6/2017.

H. A stack of wooden pallets were kept on the f loor of the Soy Butter Processing Room. The lower pallets

were sitting in water and were covered in apparent black mold and filth. These pallets were observed in

this condition and location from 3/3/2017 - 3/9/2017.

I. The nozzle to the [(ll) (4) J and [(ll) (4) 1in the Soy Butter Processing Room was observed laying

on the Processing Room floor and in standing water multiple times during the inspection as well as

during the manufacturing of I.M. Healthy SoyNut Butter Creamy cups, Lot 065171, on 3/6/2017.

J. On 3/6/2017, during production of I.M. Healthy SoyNut But ter Creamy cups, Lot 065171, the lid to the

mixing kettle was stored propped up against the floor and wall of the Soy Butter Processing Room.

K. Various hand tools used to maintain product ion equipment in the Soy Butter Processing Room were

stored on the floor and on employee walking platforms.

L. On 3/6/2017, stainless steel filling pipe was stored on the f loor of the Soy Bu!ter Packaging Room. You

· , F

DEMHTMENT OF HF.ALTH Ai\'D H UMAN SERVIC ES 1'000 AN D DRUG AO f',flNTSTR AT!ON

DISTR!CT ADDRESS AXO PHOI>.'E I>Uli.BER OATE(S) Of' I>ISPECTIOII

675 1 Steger Drive 3/3 / 201 7- 3/15/20 17* Cincinnati, OH 45237 - 3097 Fe1 UUM6ER

( 5 1 3 ) 67 9 - 2 7 0 0 fax : (51 3) 67 9-27 72 1022121

NAME Al! O TilLE ~.\(.(DtVIOVAl. TO WHOM REPORT ISSUED

Rober t C. Carl , Preside nt IRM teAM€ STREETAOORESS

Dixie Oe\·1 Produ c t s inc 1360 J amike Ave, PO Box 18310 CITY. STATE. ZJP COOE. COV:ITRY TYP£ ESTABUSH'J£:1T IIISPECTEO

Erlanger , KY 41 018 - 3 11 4 Manufacture r

EMPLOYEE(S) SIGW.l\JRE OATEISSUfO

SEE REVERSE Andrel'l M Kupper , Inves t i ga t or .J!'~::.;u 3/15/20 1 7 OF THIS PAGE Kenneth E fe l kl ey , Invest i gator X Andrew ~I KI!Wff

Na r y B Sheets , Investigator A.··:r(..,l'l r;;o;..• ~ ,. ~t.f.l.-"b~~'4W ·'

FORM FDA ~SJ (09103) P..­...r.VlOLI~ conro~· oo5ou.n: lNSPECTIONAl. OilSF.RVATTONS PAGE 4 OF ? P.~GES

-~

stated these filling pipes are no longer used and need to be discarded . ..

OBSERVaTION 3 Hand-washing facil ities lack running water of a suitable temperature.

Specifically, there was no hot wate~ to t he handwashing sink and the two-compartment sink located in the Soy Butter Processing Room. According to your maint enance supervisor, the hot water tank for these sin ks has been out 6f repair for two yea r s. Additiona lly, the hand soap dispenser for the hand sink wa s not operab le. Your Plant Manager stated he w ill sometimes use the (o) hose to wash his hands in the hand wash sink since this is the on ly hot water in the room.

OBSERVATION 4 Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanirizing.

Specifically,

A. You an d yom Plant Manager sta t ed you have not disassembled any SoyNut Butter processing equipment

and all associated piping for cle aning and sanit izi ng since December of 2015.

B. Per your Plant Manag er, your firm does not routin ely wash and sanitize sma ller pipes, pipe fittings,

gaskets, seals and the rubber (o) (plug) when broke n down fo llowing a productio n run o f SoyNut

Butter. These are all food contact surfaces.

c. During a walkthrough of your Soy Butter Pr ocessing and Packaging Rooms on 3/3/2017, a subst antia l

amountof dried apparent old SoyNut Butter residue from previous production runs was observed on

food cont act surfaces of the (6f(':l~ o 4 large mixing kettle and ro}l4) I

(o) (4)1 ). On 3/6/2017, apparent old SoyNut Butter was observed on the mechanical mixing arms insid e

the ~6B4l ~til ~4)] of t he 1Soz jar fi lling machine. Additionally the R6 (4 ) I to t his

DEPARTMENT m· HEALTH AND HU~L\NSE!tVfC.t::S FOOD AND DRUG ADr-.IINISTRATlON

DATE(S) OF INSPECTION DISTRICT ADDRESS At<D Pt<O.\:E I IUP.!SER

6751 Steger Drive 3/3/2017- 3/15/201 7 * FEI NUMBERCincinnati, OH 45237-3097 1022121(5 13)679- 2700 Fax: (513)679-2772

NA.'•'~ .A.NO Til l E OF IUOfVIt'>UAl. YOWHOM RE.POOT ISSUEO

Robert C. Carl PresidentI

F'RM NA.~.re STREET ADDRESS

Dixie De\·1 Products I nc 1360 Jamike Ave , PO Box 18310 TYPE E.STA6U SKME10' IN5PECTEOCITY. STAlE. 2JP CODE, COU:ITRY

Er l a nge r , KY 41018-3114 Manufacture r

EMPt.OV.E(S) S!QNATUI'E DATE ISSUED

1>'\.VXVAndre1·1 M Kupper, Inves t igator 3/15/2017 SEE REVERSE Kenneth E Felkley, I nvestigatorOF THIS PAGE X .Vdre·,, M Kuppe<

A-J.,._Hr~o-~ffMary B Sheets, Investigator ....,..,.. !~tyJ.~<t>..M. r-:.:$d' · S

FORM fDA ~SJ (G9A18) PR.E\10tiS enmo:o 01\SO<.ETE INSPECTlONAL OBSERVATIONS PAGES Of 7 PAGF.S

machine were also obse!Ved soiled with old SoyNi.it Butter food residue. '• •

D. A substantial amount of dried apparent old SoyNut Butter residue from previous production runs coated

non-food contact surfaces of processing equipment in the Soy Butter Processing and Packaging Rooms.

According to you, the equipment is not routinely cleaned since the SoyNut Butter product cannot come

into contact ~OJ (4)( ·. Additionally, old apparent SoyNut Butter residue heaviiY:,coated OCo) (4n control

buttons and knobs, overhead electrical cables and ~6f(4Jlpiping fixtures loca ted throughout the

Processing Room.

E . The SoyNut Butter cup conveyor belt used to convey packaged I.M. Healthy SoyNut Butter Creamy cups,

Lot 065171 on 3/6/2017, was visibly sta ined with apparent old SoyNut Butter resid ue.

'

OBSERVATION 5 Employees d i d not wash hands thowugh ly i n an ad equate hand-washing faci lity at any time their hands may have become soiled or contaminated.

Specifically, during production of I.M. Healthy SoyNut Butter Creamy cups, Lot 065171 on 3/6/2017, an employee was obse!Ved handling manufacturing equipment which was in contact with the process floor and proceeded to wash his hands in a handwash sta tio n without hand soap or hot water prior to continuing with t he m anufacturing process which involved handling packaged food ingredients and finished product containers and packaging.

OBSERVATION 6 Failure to perform microbial testing where necessary to identify possible food contamination.

Specifically, the buffer solutions and cultu re plates used by your firm to conduct internal coliform, APC and yea st

and mold testing on your firm' s finis hed products had expiration date s of 7/2016 and 10/2015 respectfully .

.

...............- ..........-...·-··-··---···-··---·---·---·--·--·----------------------------- ­

D EI'ARTi\IENT OF H EALTH ANI> HUMAN SER VICES FOOD AND DRUG ADMfNfSTRATJON

OISTRl CT ADDRESS Af:O PI-!OUE f¢UIJBER

6751 Steger Drive Cinci nnati, OH 45237- 3097 (5 13)679-2700 Fax: ( 513)67 9- 2772

NA1tE AAO t iTLE OF 11\'0fV'IOUAL TO 't\ liOM REPORT ISSUt:.O

Robert ·c . Ca r l Pr esidentI

FIRM >IA'I.E

Di xie De\·1 Pr oduc t s I nc CnY. STATE, ZiP COOE. COUUTRY

Er l ange r , KY 41018 - 3114

STREET ADDRESS

1360 Jami ke Ave, !?0 Box 18310 TYPE ESTABUSK~.~i!I:TmSPECTED

Manufa c t urer

OATE{S) ~ I: :SPE:CllO:'J

3/3/~0 1 7 -3/15/2017 * FE J f~.•W BER

.1022121 .· .

DATE ISSUED Eli.Pt.OYEE(S) SIGtl~l\JRE

JVW)mAndre\·/ M Kupper , I nvest igator 3/15/2017SEE REVERSE Kenneth .E: Fel kley, InvestigatorOF THIS PAGE X Andr.-fl ~~K"!'9tr

A-.&-....Hr~<V"'

t ..e'T,.e'.3" i o;->ejt'f A"t.""c:oo M (~{«<'$

t-1ary B Sheets, I nvestiga tor

FORM FDA JSl (09!1lS) PRI:.VfOUS E.OJliO~ OBSOLE1"'E l NSPEC.TIONAL OllSE RYAT IONS PAGE 6 OF 7 l'AG~S

OBSERVATION 7 The plant is not constructed in such a manne r as to allow tloors and ceilings to be adequately cle<:!.ned and kept clean and kept in good repair. .

Specifically, the floor s in the Soy Butter Processing and Syrup Roo ms had missing ti les or were heavily pitted, cracked or in general pdor repair throughout. Additionally, some ceiling tiles in the same rooms were observed m isaligned or in poor repair ~i th holes and/or broken tiles. Furthermore, an approximate one foot opening between t he outside of the walk-in refrigerator and warehouse room was observed along t he back wall and floor of the unit. According to your Plan t M anager, it was most l ikely caused by an employee moving a palletized

produc;t w ith a forklift.

OBSERVATION 8 Failure to provide adequate ventilation to m ini mize odors and vapors in areas where they may contami nate food.

Specifically, during production of I.M. Healthy Soy Nut Butter Creamy cups, Lot 065171 on 3/6/2017, a suspended haze was observed in the Soy Butter Processing and Packaging Room . According to your Plant Manager, t he hale is created by t he exhaust of theOCon.zrn machine and co nsists of a water and o il particulate

mix. The lid to t he large mixing kettle co n taining product was removed w hen this was observed .

O BSER VATION 9 Effective measures are not being taken to exclude pests from the processing areas.

Specifically,

A On 3/13/20 17, an opened (b)(4l bag in box (15) (4) product in your fi rm's walk-in cooler was observed with

an apparent 3" diameter rodent defiled marking that penetrated the box and product. Add itiona lly,

apparent mold was growing on the surface of the butter.

·····--,

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD fu'\/0 DRUG ADWNISTRATlON

DISTRICT ADDRESS AND PHO.\"E 1'/U).'BER

6751 Steger Drive Cincinnati, OH 45237~3097

(513) 679-2700 Fax: (513) 679-2772

N1>..ME Alm Tfll_EOF 11/DMDUAL TO WHOM REPORT ~UED

Robert c. Carl ' President FIRM NA>.~E

Dixie DeH Products Inc CITY. STATE, ZIP CODE, COUlffRY

Erlanger, KY 41018-3114

STREET ADDRESS

1360 Jamike Ave, PO Box 18310 TYPE ESTA8LISH'.'ENT INSPECTED

Manufacturer

DATE(S) OF IIISPECTI0/1

3/3/2017~3/15/2017* FEI NVI.~BER

1022121

B. An apparent fly infestation in your firm's Quality Control and Product Development Laboratory was

observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an

unplugged chest freezer. A sealed blue plastic bag was inside the freezer and according to your Plant

Manager, contained an egg product that became rotten when power was disconnected. The small

apparent flies were observed along the laboratory counters and flying throughout the laboratory.

'

OBSERVATION 10 Failure to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.

Specifically, a heavy build-up of discarded SoyNut Butter and other products coated the internal surfaces of your firm's dumpster located on the exterior of the building near the loading dock. On 3/7/2017, the dumpster's side doors were open allowing easy access for pests.

*DATES OF INSPECTION 3/03/20 17(Fri),3/06/20 17(Mon),3/07/20 17(Tue ),3/08/20 17(Wed),3/09/2017(Thu),3/13/20 l7(Mon),3/l 5/ 2017(Wed)

3/15/2017 3/15/X!17

X r·1aty B Sheets M.uy B Srects

lrMO'lti9lil:~

S)Te:ll7f. 1-'.e.ry B. Srects ·52

X Kenneth EFelkley Y.Efn;"fu EF.o~:tcy

L"l.es~:or

Sig16:1 t>r. Y.Enroetl f<c;.',;cf ·S

SEE REVERSE OF THIS PAGE

El.'f>LOYEE(S) SIGNATURE

Andrew M Kupper, Investigator Kenneth E F'elk.ley, Investigator Mary B Sheets, Investigator

.

]il'!L:tJ

X Andre.~ MKu~.per ~""MI'I<ry,..,.

~.... ,,...,n~ ""'"'M '-<w-s

DATE ISSUED

3/15/201'1

FORM I'DA .J83 (09/US) PREVIOUS EDIT! ON OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 7 OF 7 PAGI:S

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

)udgment, 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."