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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

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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