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8/21/2019 FDA Found Listeria Applied Blue Bell Creameries Brenham TX 483 05-01-2015
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SEE REVERSE
OFTHISPAGE
EMPLOVEE(S) SIGNATIJRE
Frans E. Mercado, Inve,tiqat or
Hung V. Le , I n vestiga t or
Daniell e
L
yk e
, I nvestigator
J 813ie M. Bumpas Investigator
Haba
cucV. Barrera,
I n v e
st ig
a t o r _
d_. ....
.. . f _
Ch
a
r les
B. SteiNil
ille r
, I nvestigator
0 /
::::/
Frankl in R.
Harris,
Investig-ator
Qe
oise
Connel ly
Inve.stiqator
Silatina
J\
Alridge
, I nvli s
t1ga
t or
Massoud Motaned, In
vest
i
gato
r
Matthew R.
Maddox ,
Investig ator
I'REVIOOS SDITlON OBSOLETB
INSPECTIONAL OBSERVATIONS
DAlE
ISSUe
/ 201
PAGE 1
OF4PAG
DEPARTMENT OF BEALmAND HUMAN SERVICES
FOODANDDRU
G NUNffiTR TI
ON
asTRICT ADDRESS AAI> PHONE NUMBER DATE( ) OF NSPECTION
4 0 40 Nor th Centra l Exp r e
ssw
ay, Sui te 300 0
3/1
6/2015 - 0 5 /
01/
20
15
*
FE NUMBER
Dallas
, TX 752 04
(214) 2
53-5
2 00 F
ax:
( 21 4 ) 2 5 3- 5 314 1 6 82009
Industry Inf
o
rmation
: www.fda .
gov/o
c / i ndu s t r y
AND TiLE OF INOMOVAL TOWHOM REPaUISSU
EO
TO:
Pa u l
W.
Krus
e,
C
EO
FIRM
NAM
E SIREETADDRESS
Blue Bel
l
Cr
e ame r
ie s
, L. P .
Rd
OfTY,
STATE,
ZIPOOile COI.JN
mV
Brenham, TX 77833
-4 4
1 3
Ma
nu
f
ac
ture r
This document lists obs
ervations
made by the
FD
A
representative(s
) dwing the
inspection
of
your facility. They are
inspectional
observations
,
and do
not
represen
t a
final
Agenc
y
determination regarding your compliance
. I f
you
have
an objection
regarding
an
observation, or have implemented, or plan to implemen
t, corrective
action in response to an observation
,
you may
discuss
the
objection
or
action with the
FDA representative(s)
during the
inspection
or submit this information to
FDA
at the
address
above. I fyou have any
questions,
please
contact FDA at the phonenumber and
address
above.
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
Failure to manufacture
food
s
unde
r conditions
and controls necessary to
minimize the
potential for
growth
of
microorganisms.
The following lots of products, which were manufactured ontiiQJ Iinellbetween 8/29/14 and 1121115 and subsequently
distributed into
commerce,
were
sampled
by your
fum and found
positive for
Listeria
monocytogenes
• Great Divide Bar (Bulk packaging), manufactured
on
1/12/15, lot
011217A,
and distributed between 1/13/
15
-
2/10/15.
• Chocolate Chip Country Cookie (Bulk Packaging), manufactured on 01/20/15, lot 01201
7A,
and distributed
between 1/20/ 15-2/11/15.
Additionally, your fum .ceased production on 1/30115, to undergo routine cleaning and overhauling of[GJIQJ l ine On
2/13/15, your firm received notification from
DSHS
of your products positive for
Listeria monocytogenes.
Prior to resumin
operations
on
this line, your firm swabbed thegplLine.equipment and found the following listeria positive swabs :
• 2/19/15, inside drain
of
the freezer tunnel (non-food contact surface) ofthetiiQJ lin
• 2/21115, the outside drain of the freezer tunnel (non-food contact surface)
ofthe[GJIU lin.
On 2/23/15 , your fum resumed o
pe
rations on
th4i l l l l l in
continuing to
manufacture on
3/2/15,
3/3
/15, 3/4/
15
, 3/5/
15
,
3/6/ 15, and 3/9/15 . After each of these manufacturing days your routine and Hovvever,
on 3/9/15, your firm found Listeria [ i i i Jgenes positive swabs · • • inn
contact surface) and in the underside • • chainsprocket (food contact
surface)
. During line as
manufacturing Sour Pop Apples (lot
030917A).
However, the Sour Pop Apples (lot 0309 1
7A)
were never offered
:fo
r
sale
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EMPl.OYEE(S) SIGHA11JRE ·
DATE
ISSUED
E. Morcedo, Invo.atigator
ung V. Invest iga tor
Dan1eUe Lyke, Invest1ga1:or
Jamie
M.
Blllllpas, In ve
stiqa1:or
Habacuc V. Ba r
rera,
I
nves
t
iga tor
· SEE
REVERSE
Charles B.
StQinmiller,
,
05/01/2015
Franklin R. Harr is Inve.stigator
OF
THIS PAGE
Dani3e
Conne l
ly, Inve:.tigato.r
Sil'etina R.
1\.lridge,
Inve.,ti
gator
Massoud
Hotalled,
MattllGW R. Maddox, I
nvestigator
FOR\\f
FDA
483 (09
198)
PREVIOUSBDmON OllSOLI TE
INSPECITONAL
OBSERVATIONS
PAGI 20P4
PAGI S
DEPARTMENT OF HEALTH AND
HUMAN
SERVICES
FOOD AND DRUG
AD
MINISTRATION
DIStRICT ADDRESS AND
PHONE NUMI ER
DATE($) OF INSPECI'ION
4040
North
Central
Ex
pressway
,
Suite
300 03/16/2015 - 05/01/2015 *
F
EI NU
IIBER
Dallas , TX
75204
(214) 253 -
5200
Fax:
(214)
253-5314 1682009
Industry Information: www . f da .
gov/oc/indus
t ry
NAME AND TTT1.EOF
NDIV
IDUAL TO WHOM
REPCRT
ISSUED
TO:
Paul w. Kruse,
CEO
FIRM N tE
STREET ADDRESS
Blue Bell Creameries , L. P. 1101
s Blue
Bell Rd
CtlY, STAlE, 2JPCOOE, COUNlRY
lYPE <»l'ABI.ISHMENT
INSP£CTEO
Brenham, TX
77833-4413
Manufacturer
OBSERVATION 2
The procedure used for cleaning and sanitizing ofequipment has not been shown to provide adequate cleaning and sanitizing
treatment.
Specifically,
After shutting own·lin· for cleaning and on
1
/3
0/15,
your fum received notification
from DSHS on 2/13 15 findings ofListeria monocytogenes in y our products), your firm collected .
environmental samples o • • Li
nt l l
and swabs taken at the following two locations were subsequently found posit ive
for Listeria
mo
nocytogenes:
Swab collected from the inside drain ofthe freezer tunnel (non-food contact surface) ofthe[GJIQ
lin
on 2/1 9/
15.
Swab collected from the outside drain
of
the freezer tunnel (non-food contact surface) ofthdtiJUJJiinejlon 2/21/15.
g n s
t
our firm then resumed manufacturing, cleaning and sanitizing operations fortmm)l inelon 2/23
/
15,
3/2/
15
, 3/3/15
3/
4/ l
5,
3/
5
11 3/611
and
3/9/15.
However, on
3/9/
15
,
your
finn
fuuod
Liotena
pOOtive
swabs
l i ne .
in the bottom (food contact surface) and in the underside • • chains
pr
ocket (food contact
surface). l inflwas manufacturing Sour Pop Apples ( o
030917A).
However, the Sour Pop
Apples (lot
03
091
7
A) were never offered for sale.
OBSERVATION
3
The plant is not constructed in such a manner as to prevent condensate from contaminating food and food-contact surfaces.
Specifically,
During the inspection, we observed condensate and drip throughout the facility. The following are examples of condensate
8/21/2019 FDA Found Listeria Applied Blue Bell Creameries Brenham TX 483 05-01-2015
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EMPLOYEE{S)
SlGNATIJRE
DAlE ISS\JED
Frana
E. Mercado, Investiga tor
fung V. Le, Investigator
Dan.
i e l l e
Lyke, I nvestigator
Jalllie M. BUII\pas , Investiga
tor
_
Habacuc V.
Barrera,
I nvest igator tJ
EE
REVERSE
Charles B. In ve st igato r f
Franklin
R
Harr is ,
I nvort igat o r
05/01/201
5
OF THIS PAGE
Con ne y,
In
ves t iga to r
Shat1na
R.
Alr dqe, In
vestigator
Ma.ssoud Motaited, In v
est iga
tor
Mattb.ew R. Maddox, I nvestigator
FORM
IDA
483 (09/08) PRBV OUS SOITION OBSOLII'I'E INSPECTIONAL OBSERVATIONS PAOE30F4PAGES
DEPARTMENT OFBEALTHAND HUMAN SERVICES
FOOD AND
D
RUG ADMINIS TION
DISTRICT AOORESS
AND
PHONE NUMBER
DATE(S) OF INSPEC110N
4040
North
Central Expressway, Sui te
300
03/16/2015
-
05/01/2015*
TRA
FE NUMBER
Dallas , TX
752.04
(214)
253-5200
Fax: (214)
253-5314
1682009
Indust ry Information:
www. f da.gov/oc/ indus t ry
NAME AND OF
INDIV
I
DUAL
TO WHOM REPORT
ISSUED
TO:
Paul
W. Kruse, CEO
ARM
NAMe SlREETADDRESS
Blue
Bel l Creameries , L.P. 1101 s
Blue
Bel l Rd
CITY, STATE, ZlPCOOE,COUNTRY 1'fPE
1NSPECIED
Brenham
,
TX
77833-4413 Manufacturer
that
we
observed dripping directly into ice cream products:
On 3/17/15, we observed condensate drip on l ine.ocated on the 3rd floor in production
areatf the
firm. The drip was
falling from each
of
the
l u e
hoses into the stainless steel mold. After the drip would fall on e molds, the molds
containing the drip were tiled with
mix
berry ice cream (lot 031717M).
On
3/ 18/15, we observed condensate above the filler on Pint line ocated on the
I"
floor in production
are4i
The
condensate was dripping directly into pints
ofmint
chocolate ice cream (lot 0318170).
On
3/18/15, we observed condensate
on
the filler
on
112 Gallon
limlllocated
on the first floor in production
condensate was dripping directly into 112 gallons
of
Cookies 'n Cream (lot 031817H).
On 4/21/15, we observed condensate drip on top
of
closed boxes ofice cream sandwich lids. The boxes containing ice cream
sandwich lids were staged in the sandwich mezzanine room on the second floor of the firm, under stainless steel ice cream
lines which feed ice cream into sandwich ; ruc t ion lines lids are an ingredient used in the manufacture
of
ice cream sandwiches. LinesMIDJIJ , manufacture Varu. a San ches, Mini Sandwiches (vanilla), and double
vanilla sandwiches.
OBSERVATION
4
Failure
to
clean food-contact surfaces
as
frequently as necessary
to
protect against contamination offood.
Specifically,
On 3/16/15, we observed alllofthe ingredient hoppers in blending room llwere not kept clean. The underside of the hopper
lids were caked with emulsifiers and stabilizers which had mixed with the humidity found in the room These ingredients are
added to blenderlatong with other ingredieni such as cocoa powder, and blended with raw milk. prior to entering the High
Temperature Short Time pasteurizer. Blende : room is found on the first floor of the facility
OBSERVATION 5
Failure to wear beard covers in an effective manner.
Specifically,
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.... 7
OF
THIS PAGE
SEE REVERSE
DEPARTMENT OF HEALTH
AND HUMAN
SERVICES
FOOD
AND
DRUG ADMINISTRATION
OISTRCT
ADDRESS AND
PHONE
NUMBER DATE(S) OF ti PECI ION
·
4040 North Centra l
Expressway, Suite 300 03/16/2015 -
05/01/2015
*
FEI NOAIBER
Dallas, TX
75204
214)
253-5200 Fax : (214)
253-5314 1682009
Indus
t
ry
Information : www. fda . gov/oc/ind
ustry
NAM
AND liTL.E
Of INDMOIJAI.
TO
WHOM REPORT
ISSUED
TO: Paul W
Kruse,
CEO
ARM
NAME
SIREET
ADDRESS
Blue Bell
Creameries,
L.P. 1101
s Bl ue
Bell Rd
CITY,
STATE,
ZIP
CODE, COUNTRY
TYPE
ESTI\Ili.ISHMENT
INSPECTED
Brenham,
TX 77833-4413
Manufacturer
On
3/16/15, we observed 6 employees with beards wear protective beardnets without covering the mustache portion
of
their
beards. The employees were in various areas
of
the facility, including the HTST
area,
and in areas where the firm was
actively producing products.
OBSERV
A
TIO
N 6
Failure to maintain buildings
in
repair sufficient to prevent food from becoming adulterated.
Specifically,
-
n 3/16/ 15, we observed paint on the ceiling vent directly above blender& in the Blender& andlfR.oom was chipped and
cracking. Blender& is used to add liquid ingredients and sugars into the raw milk product before it enters the
Temperature Short Time pasteurizers. We also observed that the door guards on the door at the entrance to the • •
equipment room in productionar4h ddeep grooves, preventing the surface of the doo r guards to
be
easily cleaned
.. DATES OF
INSPECTI
ON:
03/16/2015 Mon), 03/l7/2015 Tue), 03/18/2015 Wed),
03
/ l
9/20
1
5 Thu)
, 03/20/2015 Fri),
03/30/20
1
5 Mon)
, 03/3l/2015 Tue),
04/02/2015 Thu), 04/06/2015 Mon), 04/08/2015 Wed),
04/l3/2015 Mon)
, 04121/2015 Tue),
05/0
l/2015 Fri)
gator
EMPI..OYEE(S)
SIGNATURE
F
rans
E.
Mercado, In
v
es t
i ga tor
flung V.
1
In vestiga t or
Da nie l l e Lyke, Investigator
J8111ie M.
Bumpas, I nvestigator
Habacuc
V.
Inves
t igator
Cbarles
B.
S einmi l l er I
nves
Fr anklin R.
Harri s
,
lnvG::otiqator
Connel l y,
Inves
t
iga tornise
S a t 1na R. Al r
1dge,
I n
vestigator
Massoud Motamed, I nvest igator
Matthew R. Haddox, In vestigator
DATE
ISSUED
05/01/
2 0
15
FORM II1>A 483 (09188)
PREVIOUS
EDmON DBSOI..ETB INSPECI'IONAL
OBSERVATIONS
PAGE40F4 PAOES