DEPARTMENT OF BEALmAND HUMAN SERVICES

FOODANDDRUGADNUNffiTRATION

asTRICT ADDRESS AAI> PHONE NUMBER

4 0 40 North Ce ntral Expr e ssway, Suite 300

Dallas , TX 752 04
(214) 253-52 00 Fax: ( 21 4 ) 2 5 3- 5 314
Industry Info rmation : www.fda . gov/oc / i ndus t r y

DATE($) OF INSPECTION

03/1 6/2015 - 0 5 / 01/2015*

FE! NUMBER

1 6 82009

AND TilLE OF INOMOVAL TO WHOM REPaUISSUEO

TO:

Pa u l W. Kruse, CEO

FIRM NAME

SIREETADDRESS

Blue Bell Cre ame r ies , L. P .

Rd

OfTY, STATE, ZIPOOile, COI.JN'mV

Brenham, TX 77833-441 3

Manuf acture r

This document lists observations made by the FDA representative(s) dwing the inspection ofyour facility. They are inspectional
observations, and do not represent a final Agency determination regarding your compliance. Ifyou have an objection regarding an
observation, or have implemented, or plan to implement, 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. 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 foods under 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 012017A, 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 line. On
2/13/15, your firm received notification from DSHS ofyour products positive for Listeria monocytogenes. Prior to resuming
operations on this line, your firm swabbed thegplLine.equipment and found the following listeria positive swabs:

2/19/15, inside drain ofthe freezer tunnel (non-food contact surface) ofthetiiQJ lin.

2/21115, the outside drain ofthe freezer tunnel (non-food contact surface) ofthe[GJIU)lin.

lin.

On 2/23/15, your fum resumed operations on th4illlllin. 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 ofthese manufacturing days your
routine
and
Hovvever,
on 3/9/15, your firm found Listeria [iii)Jgenes positive swabs
in
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 # 030917A) were never offered :for sale.
DAlE ISSUeD

EMPLOVEE(S) SIGNATIJRE

SEE REVERSE
OFTHISPAGE

Frans E. Mercado, Inve,tiqat or

Hung V. Le, I n vestiga t or
Danielle Lyke, I nvestigator
J 813ie M. Bumpas , Investigator
Haba cucV. Barrera, I n v e stiga t o r
Charles B. SteiNililler, I nvestigator
Fran klin R. Harris, Investig-ator
Qe oise Connelly 1 Inve.stiqator
Silatina J\ , Alridge, I nvli s t1gat or
Massoud Motaned, Investi gator
Matthew R. Maddox, I nvestigator

I'REVIOOS SDITlONOBSOLETB

__ _ d_.,....

/::::/)

INSPECTIONAL OBSERVATIONS

.., __,., fA A_

/ 2015

PAGE 1 OF4PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
DIStRICTADDRESS AND PHONE NUMI!ER

DATE($) OF INSPECI'ION

4040 North Central Expressway, Suite 300

Dallas , TX 75204
(214) 253 - 5200 Fax: (214) 253-5314
Industry Information: www . f da . gov/oc/indust ry

03/16/2015 - 05/01/2015 *
FEI NUIIBER

1682009

NAME AND TTT1.E OF INDIVIDUAL TO WHOM REPCRT ISSUED

TO:

Paul

FIRM NAtE

w.

Kruse, CEO

STREET ADDRESS

Blue Bell Creameries, L. P.

1101

CtlY, STAlE, 2JPCOOE, COUNlRY

lYPE t<l'ABI.ISHMENT INSPCTEO

Blue Bell Rd

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 downlin for cleaning and
on 1/30/ 15, your fum received notification
from DSHS on 2/13 15
findings ofListeria monocytogenes in y our products), your firm collected .
environmental samples o Lintll and swabs taken at the following two locations were subsequently found posit ive
for Listeria monocytogenes:
Swab collected from the inside drain ofthe freezer tunnel (non-food contact surface) ofthe[GJIQ lin. on 2/19/15.

Ut-

Swab collected from the outside drain ofthe freezer tunnel (non-food contact surface) ofthdtiJUJJiinejlon 2/21/15.

.genes

Your firm then resumed manufacturing, cleaning and sanitizing operations fortmm)linelon 2/23/15, 3/2/ 15, 3/3/15
3/ 4/l 5, 3/511 3/611 and 3/9/15. However, on 3/9/ 15, your finn fuuod Liotena
pOOtive swabs
line. in the
bottom (food contact surface) and in the underside chainsprocket (food contact
surface).
linflwas manufacturing Sour Pop Apples ( o 030917A). However, the Sour Pop
Apples (lot # 030917A) 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
EMPl.OYEE(S) SIGHA11JRE

SEE REVERSE
OF THIS PAGE

FOR\\f FDA 483 (09198)

E. Morcedo, Invo.atigator
Hung V. Le1 Investigator
Dan1eUe Lyke, Invest1ga1:or
J amie M. Blllllpas, Investiqa1:or
Ha bacuc V. Ba r rera, I nvest igator
Charles B. StQinmiller,
Franklin R. Harris, Inve.stigator
Dani3e Connelly, Inve:.tigato.r
Sil'etina R. 1\.lridge, Inve.,ti gator
Massoud Hotalled,
MattllGW R. Maddox, I nvestigator

PREVIOUSBDmON OllSOLI!TE

DATE ISSUED

/3,
INSPECITONAL OBSERVATIONS

05/01/2015

PAGI!20P4 PAGI!S

DEPARTMENT OFBEALTHAND HUMAN SERVICES

FOOD AND DRUG ADMINIS TRATION
DISTRICT AOORESS AND PHONE NUMBER

DATE(S) OF INSPEC110N

4040 North Central Expressway, Suite 300

Dallas , TX 752.04
(214) 253-5200 Fax: (214) 253-5314
Industry Information: www. f da.gov/oc/ ind ustry

03/16/2015 - 05/01/2015*

'
:

FE! NUMBER

1682009
,.

NAME ANDllllE OF INDIVIDUAL TOWHOM REPORT ISSUED

TO:

Paul W. Kruse, CEO

ARM NAMe

SlREETADDRESS

Blue Bell Creameries , L.P.

1101

CITY, STATE, ZlPCOOE, COUNTRY

1'fPE

Brenham, TX

Manufacturer

77833-4413

Blue Bell Rd
1NSPECIED

'

that we observed dripping directly into ice cream products:

On 3/17/15, we observed condensate drip on line.ocated on the 3rd floor in production areatfthe firm. The drip was
falling from each ofthe!lue 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 of mint 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 ofCookies 'n Cream (lot 031817H).

On 4/21/15, we observed condensate drip on top ofclosed boxes ofice cream sandwich lids. The boxes containing ice cream
sandwich lids were staged in the sandwich mezzanine room on the second floor ofthe firm, under stainless steel ice cream
lines which feed ice cream into sandwich ;ruction lines
lids are an ingredient used in the manufacture
ofice 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 ofthe hopper
lids were caked with emulsifiers and stabilizers which had mixed with the humidity found in the room These ingredients are
added to blender latong 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 ofthe facility .

OBSERVATION 5
Failure to wear beard covers in an effective manner.
Specifically,
EMPLOYEE{S) SlGNATIJRE

....

DAlE ISS\JED

Frana E. Mercado, Investigator

SEE REVERSE
OF THIS PAGE

lfung V. Le, Investigator

Dan.i elle Lyke, I nvestigator
Jalllie M. BUII\pas , Investigator
Habacuc V. Barrera, I nvest igator

Charles B.
Invest igator
Franklin R . Harris, I nvortigator
Con ne lly, Inv estigat or

tJ

05/01/201 5

Shat1na R. Alr!dqe, Investigator

Ma.ssoud Motaited, Investigator
Mattb.ew R. Maddox, I nvestigator
FORM IDA 483 (09/08)

PRBV!OUS SOITION OBSOLII'I'E

INSPECTIONAL OBSERVATIONS

PAOE30F4PAGES

'

DEPARTMENT OF HEALTH AND HUMAN SERVICES

'

FOOD AND DRUG ADMINISTRATION

OISTRCTADDRESS AND PHONE NUMBER

DATE(S) OF tiSPECI'ION

4040 North Ce ntral Expressway, Suite 300

Dallas, TX 75204
(214) 253-5200 Fax : (214) 253-5314
Indust ry Information : www. fda . gov/oc/industry

03/16/2015 - 05/01/2015*

FEI NOAIBER

1682009

'

NAM" ANDliTL.E Of INDMOIJAI. TOWHOM REPORT ISSUED

TO:

Paul W. Kruse, CEO

ARM NAME

-'

SIREET ADDRESS

s Bl ue Bell Rd

Blue Bell Creameries, L.P.

1101

CITY, STATE, ZIP CODE, COUNTRY

TYPE ESTI\Ili.ISHMENT INSPECTED

Brenham,

Manufacturer

TX

77833-4413

.:>

'

:;.;

On 3/16/15, we observed 6 employees with beards wear protective beardnets without covering the mustache portion oftheir
beards. The employees were in various areas ofthe facility, including the HTST area, and in areas where the firm was
actively producing products.

Failure to maintain buildings in repair sufficient to prevent food from becoming adulterated.

Hi-

Specifically,

On 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 production
deep grooves, preventing the surface ofthe door guards to be easily cleaned.

ar4had

.. DATES OF INSPECTION:
03/16/2015(Mon), 03/l7/2015(Tue), 03/18/2015(Wed), 03/ l 9/2015(Thu), 03/20/2015(Fri), 03/30/2015(Mon), 03/3l/2015(Tue),
04/02/2015(Thu), 04/06/2015(Mon), 04/08/2015(Wed), 04/l3/2015(Mon), 04121/2015(Tue), 05/0l/2015(Fri)

EMPI..OYEE(S) SIGNATURE

FORM II1>A 483 ( 09188)

!;

OBSERVATION 6

SEE REVERSE
OF THIS PAGE

'

....---7

Frans E. Mercado, Investi gat or

flung V. Le 1 Investigat or
Danielle Lyke, I nvestigator
J8111ie M. Bumpas, I nvestigator
Habacuc V.
Invest igator
Cbarles B. S t einmi ller, I nvestigator
Fr a nklin R. Harris, lnvG::otiqator
Connell y, Invest igator
S a t 1na R. Al r1dge, I nvestigator
Massoud Motamed, I nvest igator
Matthew R. Haddox, Investigator

05/01/ 2 015

tnise

PREVIOUS EDmON DBSOI..ETB

DATE ISSUED

INSPECI'IONAL OBSERVATIONS

PAGE40F4 PAOES