8/9/2019 Inspection report for Blue Bell, Brenham

1/4

SEE REVERSE

OFTHISPAGE

EMPLOVEE(S) SIGNATIJRE

Frans E. Mercado, Inve,tiqat or

Hung V. Le , I nves

ti

ga t or

Daniell e

L

yk e

, I nvestigator

J813ie

M.

Bumpas Investigator

Haba

cucV. Barrera,

I nve

st ig

at or

_

d_. ....

t : : : J ~

..

. f

_

Ch

a

r les

B. SteiNilil l

e r

, I nvestigator

0 /::::/

F

ra

nkl in R.

Harris,

Investig-ator

Qe

oise

Connel ly

 

Inve.stiqator

Silatina

J\

Alridge

, I nvlis

t1ga

t or

Massoud Motaned, In

vest

i

gato

r

Matthew R.

Maddox ,

Investig ator

I'REVIOOS SDITlON

OBSOLETB INSPECTIONAL OBSERVATIONS

DAlE

ISSU

e

  / 201

PAGE 1

OF4PAG

DEPARTMENT OF BEALmAND HUMAN SERVICES

FOODANDDRU

G NUNffiTR TI

ON

asTRIC

T ADDRE

SS

AAI> PHONE NUMBER

DATE( )

OF NSPECTION

4040 Nor th Centra l Exp r e

ssw

ay, S

ui te

300 0

3/1

6/2015 - 05/

01/

20

15

*

FE! NUMBER

Dallas

,

TX

75204

(214) 2

53-5

200 F

ax:

(214) 253- 5314 1682009

Industry

Inf

o

rmation

: www.fda .

gov/o

c / i ndu s t r y

AND Ti LE OF I

NO

MOVAL TOWHOM REPaUISSUEO

TO:

Pau l

W.

Krus

e,

C

EO

FIRM

NAM

E SIREETADDRESS

Blue Bel

l

Cr

eamer

ie s

, L. P.

Rd

OfTY, STATE,

ZIPOOile

COI.J

N

mV

Brenham, TX 77833

-4 4

13

Ma

nu

f

ac

turer

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 represent a final

Agenc

y determination regarding your compliance. I fyou

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

orsubmit

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.

S p e c i ~ c a l l y

The

foll

owing lots of

products, which were manufactured ontiiQJ

Iinellbetween

8/29/14 and 1121115 and subseque

ntly

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 ofthe 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 ~ j

routine

and

Hovvever,

on 3/9/15, your firm found Listeria [ i i i Jgenes positive swabs · • • in ~ ~ o dn

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

8/9/2019 Inspection report for Blue Bell, Brenham

2/4

EMP

l.OYEE(S) SIGHA11JRE ·

DATE ISSUED

r a n ~

E. Morcedo, Invo.atigator

ung V. Invest iga tor

Dan1eUe Lyke, Invest1ga1:or

Jamie

M.

Blllllpas, Inve

stiqa1:or

abacuc V. Bar

rera,

I

nves

t

iga tor

· SEE REVERSE

Charles B.

StQinmiller,

I n v e s t i < ~ a t o r

,

05/01/2015

Franklin R. Harr is , Inve.stigator

OF THIS

PAGE

Dani3e

Connel

ly, Inve:.tigato.r

Sil'etina R.

1\.lridge,

Inve.,ti

gator

Massoud

Hotalled, I n v e s t i < ~ a t o r

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 D

RUG AD

MINISTRATION

DIStRICT

ADDRESS

AND PHONE NUMI ER

DATE($) OF

I

NSPECI'ION

4040 North

Central

Ex

pressway

,

Suite 300

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

FEI

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 NDIVIDUAL TOWHOM REPCRT

ISSUED

TO:

Paul w. Kruse,

CEO

FIRM

N tE

STREET ADDRESS

Blue Bell Creameries , L. P. 1101

Blue

Bell Rd

CtlY, STAlE,

2JPCOOE,

COUNlRY

lYPE

8/9/2019 Inspection report for Blue Bell, Brenham

3/4

EMPLOYEE{S) SlGNATIJRE DAlE ISS\JED

Frana

E. Mercado, Investigator

~ ~

fung V. Le, Investigator

Dan.

i e l le

Lyke, I nvestigator

Jalllie M. BUII\pas , Investiga

tor

_

Habacuc V.

Barrera,

I nvest igator tJ

EE

REVERSE

Charles

B. t e i n m i Inve st igato r f

Franklin

R

Harr is ,

I nvort igat o r

05/01/201

5

OF THIS

PAGE

~ i s Conne 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

DEPARTMENTOFBEALTHANDHUMAN SERVICES

FOOD AND DRUGADMINIS TION

DISTRICT AOORESS AND PHONE NUMBER

DATE(S) OF INSPEC110N

4040

North

Central Expressway,

Sui t e 300

03/16/2015

-

05/01/2015*

TRA

FE NUMBER

Dallas , TX

752.04

(214)

253-5200

Fa

x:

(214)

253-5314

1682009

Indust ry

Information: www. f da.gov/oc/

in

dus t ry

NAME AND   OF INDIVIDUAL TO WHOM REPORT ISSUED

TO:

Paul

W. Kruse, CEO

ARM NAMe

SlREET

ADDRESS

Blue Bel l

Creameries ,

L.P.

1101

s Blue

Bel l Rd

CITY, STATE, ZlPCOOE,COUNTRY 1'fPE T ~ T

1NSPECIED

Brenham

,

TX

77833-4413 Manufacturer

thatwe 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

areatfthe

firm. The drip was

falling from eachofthe

! 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

r e a ~ e

condensatewas 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 ; ruct ion lines h 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

blenderlatongwith 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,

http:///reader/full/Mattb.ewhttp:///reader/full/Mattb.ew

8/9/2019 Inspection report for Blue Bell, Brenham

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... 7

OF THIS PAGE

SEE

REVERSE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD

AND

DRUG ADM INISTRATION

OISTRCT

ADDRESS AND

PHONE

NUMBER

DATE(S) OF ti PECI ION

· 

4040 North Central

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,

ZIPCODE, 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 portionof their

beards. The employees were in various areas ofthe facility, including the HTST area, and in areas where the firm was

actively producing products.

OBSERVATION6

Fai

lure 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.oomwas 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 easilycleaned

..

DATES OF

INSPECTI

ON:

03/16/2015(Mon), 03/l7/2015(Tue), 03/18/2015(Wed) ,

03

/l9/2015(Thu), 03/20/2015(Fri), 03/30/201

5(Mon)

, 03/3l/2015(Tue),

04/02/2015(Thu),

04/06/20

15(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

Investiga t or

Daniel le L

yke,

Investigator

J8111ie M. Bumpas, I

nvestigator

Habacuc

V.

a r r e r a ~

Inv

es

t igator

Cbarles

B.

S einmi l le r , I

nves

 

Fr anklin R. Harr

i s

,

lnvG::otiqator

Connel l y,

Inves

t

iga tor

nise

S a t 1na R. Al r

1dge,

I n

vestigator

Massoud Motamed, I nvest igator

Matthew R. Haddox, Investigator

DATE

ISSUED

05/01/

20

15

FORM II1>A 483(09188)

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EDmON DBSOI..ETB

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