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FDA Peanut Inspection Reports

FDA Peanut Inspection Reports

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Inspection reports of a Georgia peanut processing plant at the center of a massive, nationwide salmonella outbreak show the company operated in unsanitary conditions and knowingly shipped products contaminated with strains of salmonella.
Inspection reports of a Georgia peanut processing plant at the center of a massive, nationwide salmonella outbreak show the company operated in unsanitary conditions and knowingly shipped products contaminated with strains of salmonella.

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Published by: Washington Post Investigations on Jan 29, 2009
Copyright:Attribution Non-commercial

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09/17/2013

 
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J>EJ:>AATMENT
OF HEALTH
AND HUMAN
S E ~ V l C ~ S
 
fOOD
ANO
DRUG
ADMINIstRATION
C l ' ~ ' ' ' ' ' ' ' '
 
AND
PHONE
NUUBER
DA'!'E(S)
OF
''''''''''''''''''
(b)(4)
(b)(4)
(b)(4)
(b)(4)
(b)(4)
(b)(4)
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(b)(4)
"""R=
60
Eighth
Street
NE
01/09/2009
-
01/27/2009*
FEINUWBER
Atlanta"
GA
(404)
253-1161
Fax;
(404)
253-1202
103685'7
Industry
Information:
www.fda.qov/oc/1ndustry
NAMEIoH:JTm.EOF'NUlVlUV"C
, v ~ " " " , ~ I l I 8 U E C
 
TO:
Sammy
L-
Lightsev,
Plant
Operations
Manager
FIRMttAME
S T R = , " ~
 
Peanut
Corporation
Of
America
14075
Magnolia
St
CITY.
sTATE,:u'
<;001:,
CQUNTRV
""
' , " A 8 L ~ > I T
'N
.....
"'
.....
Blakely,
GA
39823-1881
Peanut
Roaster/Peanut
Butter'and
Paste
Manufacturer
This document
listS
observations made by the PDA l'epresentative(s) during the inspection
of
your facility, They are inspectiollalobservations,
and
do not represent a
final
Agency determination regarding
YQllr
compliance.
If
you
have
an
objection regar(ting
an
observation, or have
implemented,
Or
plan
to
implement, corrective action
in
response
to
an
obsetvatiOll,
you
may discuss
the
objection
or
IlCtion
with
the FDA representative(s) during the inspection
or
submit
thiS
information
to
FDA
at
the
IIddress
above.
If)'Clu
have
any
questions, please contact FDA.at tbe phone number and address above.
..
DURING AN
INSPJ;cnON
OF YOUR FIRM
W ~
 
OBSERVED:
OBSERVATION 1
Fajlure to manufactUre foods
undet
conditions
and
controls necessary to minimize
the
potential
for
growth
of
microorganismsand contamination.
S ~ i f i c a l l y .
 
the
fll'11ts
own
intemaJ.
microbiological testing found
the
following:Salmonella
Typhimurium:
Peanut
paste
under
l o ~
 
#
8278
was
found contaminated
with
Salmonella
T Y P ~
by
privatelaboratory
testing
qonducted
by
the
fmn.
Ater
the
fum
retested the product and received a negative status. the
fum
shipped
_lb.
of
the
product
in
interstate commerce. Additionally, this peanut paste was manufactured.on
9/26/08 from
lb. totes
of
roasted
peanuts
received
on
9/25/08.
The
lots
of
roasted peanuts received
on
9/25/08
were
~ d u c e
 
the following products
that were
also·shipped
in
interstate
commerce:!ltotes
were
used
to
m a n u f a ~
 
eanutbutter under
lot
#
8276;
one
tote
was
used
to
manufacture
p e a n u t b u ~ _ ~ r
 
underlot
277
a n ~
 
,"und.q·lot#'8277.
.
----
-,--
-------:.--
Salmonella
Anatum:
P e a n u ~
 
Butter
manufactuied
on 8/1l/08
under
Jot
#
8220
and
#
8224
tested positive for
Salmonella
Anatum
by
a private
laboratory.
After the
finn
retested
the product
and received
a
negative
status.
the product
was
shipped
in
interstate commerce.Salmonella Anatum:
Peanut
Meal
and
Medium
Chopped Granules manufactured
on
September 24,
2008
wu:1er
lot
#
8268-tested positive for
Salmonella
Anaturo
by
a private laboratory. After the
fum
retested the product and received a negativestatu9. the
product
was
shipped
in
interstate commerce.Salmonella
(no
strain
identified):
Medium
Chopped
Granules manufactured
on
June
16,
2008
under lot
#
8168
tested positivefor Salmonella
by
a
private
Laboratory.
After
the
finn
retested
the
product
and
received a negative status, the product wasshipped
in
interstate
commetce.
Salmonella
(no
strain
identified):
Small
Chopped
Granules
manufactured
on
June
9. 2008
under
lot
#
8161
tested positive forSalmonella
by
a private laboratory. After the
finn
retested the
product
and received a negative status, the product was 9hipped
E M l " U J n ; " I ~ 1
 
SlGNAnJREOATEISllUEO
Janet
B Gray,
rnvestiqa.tor
fl!JV
'Darcy
E.
Brillhart,
Microbiologist
sandra
r.
Gaul,
Investigator
SEE REVERSE
Robert
P.
Neligan,
Investigator
;;z,rA/
01/27/2009
Of
THIS PAGE
Lesley
K.
Satterwn1te.Microbiologist
T\'Iaresa
L.
Stewart,
Investigator
'(1S
.
.l'Ql'.M
I'D"
.483/ll4I03)
fMVlDWmrtlO»OllSQJ..lml
lNSl'EC'ttONAL
01JSERV
A
nONS
PAOli I 01'
&
PAGes
 
(b)(4)
~ ~ A N U T
 
CORPORATION
PAGE
03
~
 
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.
.
DEPARTMENT
OF
HEALTH
AND
JJ.1JMAN
SERVICES
FOOD
Nm
DRUG
ADMtNtSTRATION
DISTRICT ADDRESS AND PHONE NUMBER
01/09/2009
-
01/27/2009*
60
Eighth
Street
NE
F5'NVM8ER
Atlanta,
GA
30309
(404)
253-1161
Fax:
(404)
253-1202
1036B57
Industry
Information:
www.fda.aov/oc/industry
NAME...,.,DTITI,EUl"
1 ~ V ' w , , -
" ~
 
TO:
Sammy
L.
Liqhtsev, Plant
Operations
Manager
6TREeT ADDlIES6
"""NIl"",
Peanut
Corporation'
Of
America
14075
Magnolia
St
CITY.
STATE.
ZP
CODE. COUNTRY
I
TR:
~ " " A I l U l l i H E H T
IN!§'ECTElI
39823-1881.
Peanut
Roaster/Peanut
Butter'and
Paste
Manufacturer
,in
interstate commerce,Salmonella (no sttain identified): peanut
Paste
manufactured on
January
25. 2008
under
lot
#
8028 tested
positive
for
Salmonella
by
a private laboratory. After the
fum
xetested
the
product
and received a
negative
status. the product
was
shipped
in
interstate
commerce.
SabnoneUa (no
strain
identified):
Medium Chopped
Gnmules
m:mufactured
on
January 24, 2008upder
lot
#
8024
testedpositive
for Salmonella
by
a
private laboratory. After
the
firm retested
the
product
and
received
a
negative
status,
the
product
was
shipped
in
interstate
conunerce.Salmonella (no strain identified):
Small
Peanut
Granules
manufactured
in
July
of
2007
undeJ:
lot
#
n06
tested
positive
for
Salmonella
by
a
private laboratory. After
the
fum
retested the
product
and received a
negative status, the
product
was
shipped
, in interstate commerce.
Salmonella (no strain identified): Swall Peanut Granules manufactured in July
of
2007
under
lot
#
7192A
tested
positive
fot
Salmonella
by
a
private
laboratory.
A.fter
the firm retested the
product
and
received a
negative
status,
the
product
was
shipped
in
jnterstate commerce.Salinonella (no strain ideJltified): Medium Peanut
Gr.muJes
manufactured
in
July
of
2007
under lot
#
7190B
,,tested
positive
for SahnoneUa by
a
private
laboratQry.
After
the
fiun.
retested the
product
and
receiv¢
a
negative
status;
the
(b)(4)
' ~ d u c ~
 
was shipped'in interstate commerce. --, "
-
Salmonella
(no strain
identified): Oil-Roasted
Salted
P e a n u t s _ ~ . ~ ~ f ~ c ~ r e d
in
July.of2007under
Jot
#,
:7.190
--
--
----
--
"B19-1Rtested
positive
forSalniOilella'1:iy7pnvat'e
laboratory,
After
thefum
retested
theproductandreceiveda
negative '
status,
the
product
was
shipped
in interstate
cominerce.Salmonella
(no
strain
identified):
Small Peanut
Granules
manufactured
in
June
of
2007
under
lot
#
7157
tested
positive
for
Salmonella
by
a
private laboratory.
After the
fum
retested
the
product
and
received
a
nega.tive status, the product
was
shipped
in
interstate corrone,;ce.
OBSERVATION 2
Failure
to
maintain
equipment,
containers and utensils
used
to
convey. hold, and store
food
in
a
manner
that
protects
againstcontamination. . "
Specifically,
the
peanut
paste
line
was
not
cleaned
after
the
SahnoneUa
Typhimurium was
isolaa:d
nom
the
peanut
pastemanufactured
on
September 26,
:2008
(lot
#-
8278).
The
firm
continued
to
manufacture
peanut paste
in
this
system
from
9 / 2 ~ / 0 8
 
to
the begimrlng
of
this
inlipection on
1I9/09_1ots
of
peanut
paste
have been manufactured
on
this line
between
9/26/08
and
1/9/09.'
,
EMf'U)YEe(ll)
""'NII1VRE
Oil
E
I ~ . U E O
 
Janet
B
Gray.
Investigator
~ t r
 
Darcy E.
Bril!hart.
Microbtologist
SEE REVERSE
Sandra
I.
Ga1)).,
InvEstiga1:or
~
 
/
Robert
P.
NeHgan.
I n v e s t i g a t o r ~ A - v
 
01/27/2009
OF THIS
PAGE
Lesley
K.
Satter
...
h 1 ~ e ,
 
Microbiolog1st
t'hez:esa
L.
stewart.
In''estiga-cor
-,7
...
'\
'
lNSPECYIONAL
OJlSl:RV
A
nONS
PA.<)F.1 OF
6 910065
 
PEANUT
CORPORATION
PAGE
04
. .
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..
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, .
,',
..
: ~ : : . ~ : .
 
..
~
 
'.,
DEI'ARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
[1000
AND DR.uG
AOMINISTRA'llON
DJlTE(SIOF
IN9PECTIONDIllTRICT At>ClRES\lAND PHONE
NU"'8ER
01/09/2009
-
01/27/2009*
60
Eighth
Street
NB
FElNUMSER
Atlanta,
GA
30:309
(404
)
253-1161
Fax:(404)
253-1202
1036857
Industry
Information:
www.fda.Qov/oc/industry
NAME
..........
~
 
uF
1N01VlDUA<.
ToWHOM
~ T
I$SUI\O
TO:Sammy
L.
Ligh.tsey,.
Plant
Operations
Manager
(b)(4)
StREET
J \ D D R , ~
14075
Maqnolia
st
I'"""""'"''
Peanut
Roaster/Peanut
Butter'and
Paste
Manufacturer
FIRM NAME
Peanut
Corporation
Of
America
ClTY. STATE.
2IP COOE.
COUNTRY
(b)(4)
GA
39823-1881lakiely,
There
are
no
records to document
the
c1eanin.g
of
the peanut paste line after Salmonella was detected
in
peanut
pastemanufactured
on
January
25.2008
(lot
#
8028).
The
firm
ccntinued to manufacture peanut paste
in
this
system.
OBSERVATION 3
Failure
to
perfOIm mechanical manufacturing steps
so
as to prQtect food against contamination.Specifically, this
firm
recognizes the roasting step as the control point for eliminating microbiological contamination
in
rawmaterial!l. However,
this
fum
has
1l.ot
established the effectiveness
oftbe
temperature, volume.
or belt
speed specific to this
.
roaster to assure it is adequate as a kill step for pathogenic bacteria. Additionally, the firm's records
of
the roaster'stetnperature are inadequate
in
that dates bave
been
left
off
of
several eirculax recording charts.
For
example,
in
August 2008threedays
of
recordingchartswere
not
dated;
in.
September2008tworecordingchlUtswere
not
dated;
in
October
2008
sixcharts
were
not
dated;
in
November
2008
·24 days
of
reeording charts were
not
dated; and
in
December 2008 and 1anuary
2009
no
temperature recording charts were dated.
OBSERVATION 4
----
.
Failure to store finished food under conditione that would protect againstmicrobiat-C::ontiiInination.
Specifically,
On
1/9/0.2()()()
lb.
_totes
of
xawpeanuts
_were
obsexvedtobe-stored-directlynext.
to
2000
lb:
totes
~
of
flriishea;--'
roasted
peanuts
in
the finn's pr:oductionlpackaging room. The totes
of
finished product included the following: HoneyRoasted Peanuts under:
lot
#
8339;
Dry
Roasted Peanuts
undeJ,'
lot
#
9002; Peanut
Meal under
lot
#
9005;
and Dark RoastedPeanuts (plll)te
~ e )
 
under
lot#
9009.
~ t e s
of
raw
peanuts wereall
under
lot
#
40147.
On
1/26/09,
an
additional2000lb. tote
of
taw
peanuts under
lot
#
16195-08
was
observed
to
be stored
in
the production/packaging room along with the samelots
of
f.inished goodslistedabove.
It
wasvisuanydifficulttodiscernwhich
of
thesetoteswerefinishedproductsandwhichwere
raw
products.
The
abovetotes
of
finishedproductwerestored
within
15
feet
of
afloorcrackwhere
an
enviroronenta.Jswab wascollected
on
1/10/09
and found positive
for:
Salmonella Senftenberg.Also, one environmental swab collected
on
1/10/09
from the futished product cooler floor (beside the south wall) was foundpositive forSalmonellaMbandaka.
The
swab
locationwaswithin3feet
of
pallets
of
finishedproduct.
Mold
was
observed growing
on
the ceiling and walls
in
the firm's cooler used for finished
product
storage. In addition. waterstains were observed running
down
from the cooling unit fans
in
the cooler.
On
1110/09,
pallets
of
finished product werest01'ed
directly
beneath this unit.
EM""
RE
. bATE 'l>SUEO
.:ranee B
Gray,
rnVe:ltigAtor
(/J6-
Darcy
E.
Brillhart,
M i c r p b ~ o l o g i s t
 
S ~ n d r a
 
I.
Gaul,
I n v e s t i g a ~ o r
SEE REVERSE
Robert
P.Nel1gan,
l n v e 8 ~ 1 g a t ~ ~ ~
01/27/2009
OF THIS PAGE
Lesley
~ .
 
Satterwhite,
M i c r o b ~ o l o g i 8 ~
Theresa
L.
Stewart:,Investigator!'-;';;"
fORMFDA
483 (lW03}
PlI£mlla
EllIUOll
Ol/.!OLEl'B
JNSPECTlONAJ., OBSERV;\
noNS
'I\OE
l
Of
6
PAGES

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