·DEPAH.HlEi' ff OF HEA LTH AND H UMAN SERVICES FOOD AND DRUG AD:'.UNISTRATION DISTRI CT ADDRESS AM> PHm.'E 1.'\," ·' Bffi 6 OATE(Sl Cf' 111 SPECTJO:I 3/3/2017-3/15/2017* fiil 1022121 J AJ..'O Tm..E OF INOMOUAl TO \Mi C!'.t REPORT ISSUED Rober t C. Carl I Pres i dent F IRM NA ME Dixie De1-1 Product s Inc STReET AOORo$$ 1360 Jamike Ave, PO Box 1 8310 CrrY. STATe', Z•PCOOE. COliNTRV Erlange r, KY 410 18-311 4 iYPEE.STABUSHI,.\.ENT IHSPECf£0 Man ufac t urer This document lists observa tions m ade by the FDA representativc(s) during the i nspection o f]•our facility . T hey are i nspect i onat' observations, and do not a final Age ncy determi nation regarding your comp li ance. If you have an objectio n re gar ding an observati on, or have .impl emented, or plan to implement, corrective in response 10 an observation, you may discuss t he objection or act ion wi th the F DA rcprcs cntativc(s) duri ng the i nspection or submit this information to FDA at the address above. If you have any quest i ons, please contact FDA at the phone number a nd address above. DURING AN INSPECT ION OF YOUR FIRM WE OBSERVED: OBSERVATION 1 ; Failure to manufact ure an d package foods under conditions and controls necessary to mi ni mize the potential fo r growth of microorganisms and contamination. Specifically, A. Yo ur fir m does not conduct a kill st ep f or SoyNu t Butter product remaining in your fir m's mi xing k ettle left over f rom a production ru n. Yo ur Pl a nt Manager stated, up to R IJ) (4 ); may rema in in the ke ttle ove rni ght or weekend prior to resum ing production. Yo u and yo ur Pl ant Manager stated the (41 I ! the kettle is shut off when product rema i ns in the kettle overnight and/or over the weeke nd. B. Accord ing to your Plant Ma nager and Ma intenance Supe rvi sor, yourR il> (4} machine, used for fine mixi ng of the SoyNut Butter and OC o) (:it) t, ro ut inely shuts off during processing. Y our Pla nt Manager stated t hi s occurs 1-2 ti mes per day and, this pro bl em has persisted for app roxim ately 15 years despite repeated mai nt enance in tended to correct the problem. c. Your fir m monitors the SoyNut (4} 1 with an[ b} (':l 0 the rmomete r. Your Pl ant Manager s tated he has never veri fi ed the accuracy of th is instrument. D. Acco rd ing to yo u and your Plant Ma nager, your te mperature probe and chart recorder, initia ll y e ngi neered to veri fy and record f o) (4) J of product in the large mix ing kettle, js not fun ctio ni ng properly and has not been used fo r we ll over a year. E. D
Transcript
·DEPAH.HlEi'ff OF HEALTH AND H UMAN SERVICES FOOD AND DRUG AD:'.UNISTRATION
DISTRICT ADDRESS AM> PHm.'E 1.'\,"·' Bffi
6OATE(Sl Cf' 111SPECTJO:I
3/3/2017-3/15/2017* fiil NV~~aeR
1022121
J
NAl.~EAJ..'O Tm..E OF INOMOUAl TO \Mi C!'.t REPORT ISSUED
Rober t C. Carl I Pres i dent F IRM NAME
Dixie De1-1 Product s Inc STReETAOORo$$
1360 Jamike Ave, PO Box 18310 CrrY. STATe', Z•PCOOE. COliNTRV
Erlanger, KY 410 18-3114
iYPEE.STABUSHI,.\.ENT IHSPECf£0
Man ufact urer
This document lists observations made bythe FDA representativc(s) during the inspection of]•our facility. They are inspectionat' observations, and do not r~present a final Agency determinationregarding your compliance. If youhave an objectionregarding an observation, or have.implemented, or plan to implement, corrective a~tion in response 10 anobservation, you may discuss the objection or action with theFDA rcprcscntativc(s) during the inspectionor submit this information to FDA at the address above. If you have any questions, please contact FDAat 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 firm's mixing kettle
leftover from a production ru n. Your Plant Manager stated, up to RIJ) (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 weeke nd.
B. According to your Plant Manager and Ma intenance Supervisor, yourRil> (4} machine, used for fine
mixing of the SoyNut Butter and OC o) (:it) t, routinely shuts off during processing. Your
Pla nt Manager stated this occurs 1-2 times per day and, this problem has persisted for approximately 15
years despite repeated maintenance intended to correct the problem.
c. Your fir m monitors the SoyNut Butter ~ll} (4} 1with an[b} (':l0 the rmometer. Your Plant
Manager stated he has never verified the accuracy of this instrument.
D. According to you and your Plant Manager, your temperature probe and chart recorder, initially
e ngineered to verify and record fo) (4) J of product in the large mixing kettle, js not
fun ctioni ng properly and has not been used for well over a year.
E. D
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
EJ.IPI.O""E(S) S IGI.!J\TlJI\E DAlE ISSUED
lrU(Z:l1SEE REVERSE Andre1·1 M Kupper , I nvest i gator 3/15/2017 OF THIS PAGE Kenne t h E Felkl e y, I nvest i gator X 1-riJre:.•t ~I K•opper
"-"-'-"' ' :.;or;«Mary B Shee t s, Inves t igat or 1':'~-:ll
$ ~i ""' 'Y kQ- H. t~a..-$
f 0&\1 fDA l 8J (09t1l&) PI![\10US EDmONO!!SOI..F.TE lNSI'EC'I'IONAL OOSERVATlONS PAGE 3 OF 1 P,\(JES __.... ··~bll
DEPARTMEi\T OF HEALTH AND H~I,\N SERVICJ::S FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS A~O FHO~.'E IOV!/ BER DATE(S) OF IIISPECTIOil
675 1 S tege r Dr i v e 3/3 / 2 0 17 - 3/1 5/201 7* FEI I:VMSERCi ncinnati , OH 45237 - 3097 1022121(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 dentI
FlRM NA'J.E STREET ADORE$$
Di xie Dew Products I nc 1 360 J ami ke Ave , PO Box 18310 .. CITY. SfATE, Z•P COOe, COUNTRY T'ff'E ~STAS"SH't£1/T IIISPECTEO
Erlange r , KY 410 18-3114 Manu f ac tur e r
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
d ean 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 filt h.
G. The interior of the (15) (4) J bulk soy oil tote your firm used to manufacture the[(15) (4) J SoyNut
Butter[(or(4r l l ot!(5H 4r 1on 3/ 6/2017, was observed soiled with brown apparent residue.
Accord ing t o your Plant Manager, these totes are never cleaned. Addit ionally, 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 filt h. These pallets were observed in
this condition and location from 3/3/2017 - 3/9/2017.
I. The nozzle to the[(l5) (4) j and [(l5) (4) 1in t he 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 ot,(5) (4) 1SoyNut Butter 1(15) (4) I, Lot 1(5) (4} J, on 3/6/2017.
.. J. On 3/6/2017, during prod uction of(5) (4) SoyNut But ter 0C5) (4) \, the lid to the
mixing kettle was stored propped up against the floor and wall of the Soy Butter Processing Room.
K. Va rious hand tools used t o maintain product ion equipment in the Soy Butter Processing Room were
stored on the floor and on employee walking plat forms.
L. On 3/6/2017, stainless steel filling pipe was stored on the f loor of the Soy Bu!ter Packaging Room. You
·
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
machine were also obse!Ved soiled with old SoyNi.it Butter food residue. '• •
D. A subs tantial 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)( ·. Addit ionally, 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 Rll) (4y-j SoyNut Butterf ll) (4) I Lot~DJ (4)l 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(ll) (4) 1SoyNut Butter(DJ (4) ;, Lot~DJ (4)'Jon 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 pa ckaged 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 dates of 7/2016 and 10/2015 respectfully .
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. .
Specif ically, the f loor s in t he Soy Butter Processing and Syr up Rooms 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 isalig ned or in poo r repair ~i th holes and/or bro ken tiles. Furthermore, an approximate one foot open ing bet ween t he outside of the wa lk-in refrigerator and warehouse room was observed along t he back wall and floor of the uni t. According t o your Plant M anager, it was most l ikely caused by an emp loyee moving a pall etized produc;t w ith a fo rklift.
OBSERVATION 8 Failure to provide adequate ventilation to m ini mize odors and vapors in areas where they may contami nate food.
Specifica lly, during production of ~ll) (4) 1SoyNut Butter[(ll) (4) h Lot r 6)l4)l on 3/6/2017, a suspended haze was observed in the Soy Butter Processing and Packaging Room . Acco rding t o yo ur Plant Manager, t he hale is created by the exhaust o f the0C6)l4n machine and consists of a water and o il particu late mix. The lid to t he large mixing kettle containing product was removed w hen thi s was observed .
OBSER 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 apparen t 3" diameter rod ent de filed marking that penetrated the box and product. Add itiona lly,
appare nt mold was growing on the surface of the butter.
·····--,
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.
Andrew M Kupper, Investigator Kenneth E F'elk.ley, InvestigatorMary 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."
