inspection report for blue bell, alabama

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

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SEE REVERSE

OF THIS PAGE

EMPLOYEE

( )

SIGNATURE

~

Patrick c. Dooley, n v e s t i g t o ~ ~ '

~

Lezette

M.

Earhart,

Inves

t igator

Thomas

B. Smith, Investigator

Andrew F. Saunders,

Investigator

Wilvor

K.

Butler,

Investigator

Jus t in N. ns o

n

Investigator

DATE ISSUED

04/30/2015

FQR)1

F

DA 483

(09108) PREVIOUSEDITION OBSOLETE

I

NS

PEC

TI

ONAL OB

SE

RVATIONS

PAGE I

OF

4 PAGeS

-

'/. ott/}

DEPA

RT

MENT

OF

HEALTH AND HUMAN SERVICES

FOOD

AND

DRUG ADMINISTRATION

DISTR

ICT ADDRESS AND PHONE

NVMBER

404 BNA

Dr . Bldg . 200 ,

Ste .

500

Nashvi l l e ,

TN

37217-2597

(

615)

366-7801

Fax: 615) 366

- 7802

I ndus t ry In format i

on:

www .

fda

. gov/oc / indus t ry

DATE S OF INSPECTION

04/06/2015

-

04/30/2015*

FEINUMBER

1019788

NAME AND TITLE

O

INDIVIDUAL TO

WHOM

REPORT ISSUED

TO :

Kevin D.

Wood,

Genera l

Manager

F RM NAME

Blue Bel l

Creamer ies Inc

STREET ADDRESS

423

N Norton

Ave

CITY. STATE. ZIP CODE. COUNTRY

Syl acau ga,

AL 35150-2009

TYPE ESTABLISH

MENT

NSPECTED

Manufac tu rer

This document lists observations made by the FDA rcpresentative(s) during the inspection

of

your facility. They are inspectional

observations and

do

not represent a final Agency determination regarding your compliance.

If

you 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 su bmit 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 OBS ERVED:

OBSERVATION

1

Failure to perform microbial testing

where

necessary to identify possible food contamination.

Specifically,

You stated the results of

your samp

ling for environmental pathogens on non-food contact surfaces as defined in

your

- written procedure entitled Plant Environmental Testing were used as an indicator in determining whether the

cleaning and sanitization

program

was effective. However, this sampling

program

failed to include the following:

a. Sampling of food contact surfaces

b. Determination

of

any preventive action needed in respon

se

to the possible contamination.

c. Determination of the impact

on

the products produced on the affected date.

d. Determination

of

the Listeria spp. associated with the presumptive positive results.

OBSERVATION 2

Suitable outer garments are not worn that protect against contamination of food and food contact surfaces.

Specifically on 4/20/20 15,

An employee's shirt came into direct contact with the interior liner

of

an ingredient

container

while the employee was loading

the ingredients into Fruit Feeder

li

on

the - line during production

of

Bride's Cake Ice Cream.

The

employee,

who

was

not

dressed in the appropriate Blue Be ll ou t

er

garment, was wearing a shirt

which

appeared soiled and with several

holes.



EMPLOYEE S) SIGNATURE

Patrick

c. Doo l

ey,

Invest igator f

DATE ISSUED

Lezette

M.

Earhart , Invest igator

SEE REVERSE

OF THIS PAGE

Thomas B.

Smith,

Invest igator

Andrew F. Saunders, Invest igator

Wilvor

K.

But ler , Inves tiga to

r

04/30/20

15

Jus t in

N.

He

nson, Invest igator

FORMFDA 483 (09108)

PREVIOUS t,DmON OBSOLETE INSPECTIONALOBSERVATIONS

PAGE 2

OF

4 PAGES

DEPARTMENTOFHEALTH AND HUMAI'i SERVICES

FOOD AND DRUG ADMINISTRATION

DISTRICT

ADDRESS

AND

PHONE NUMBER

DATE S)

OF

INSPECTION

404 BNA Dr .

Bldg

. 200,

Ste. 500

04/06/2015 -

04/30/20

1

5*

FE INUMBER

Nashvi l le

TN 37217-2597

(615) 366

-

7801

Fax

:

(615) 366

-

7802 1019788

Indus try Informat ion

:

www.fda

.

gov/oc/ indus try

NAME ANDm OF INDIVIDUAL TO WHOM REPORT ISSUED

TO : Kevin D. Wood,

General Manager

FIRM NAME STREE T AOORESS

Blue

Bel l

Creameries I nc

423

N

Norton

Ave

C

TY

STATE

ZIP

CODE COUNTRY TYPE ESTABLIS

HMENT

INSPECTED

Sylacauga,

AL 35150 - 2009

Manufacturer

OBSERVATION 3

Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food

additives.

Specifically,

I) On 4/20/20

15,

several pieces

of

filling equipment including an

and gaskets were

observed

in

an employ

ee

hand sink immediately following the line after production.

The equipment was stored

in

the sink while a COP tank was available for adequate of equipment

approximately - from the sink.

2) On 410/2015, the . used

in

the chocolate blending room, was stored

in

a unclean metal milk can between

uses. The hose connecting the and pump was dirty and was located directly over the storage container.

OBSERVATION

The design and materials

of

equipment and utensils does not allow proper cleaning.

Specifically on 4/20/2015,

(b ) (4 )

I) A folded piece of was observed to be wrapped with masking

b) 4)

tape covering approximately

halfof

the tool. The tool was being used to on

Cone i n e directly adjacent to exposed Nutzo lee Cream Cones.

2) A space heater was observed fastened to the production equipment with duct tape directly under the chocolate tray

(b)(4)

whic during production ofMoooBars.

OBSERVATION 5

All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any

source.

Specifically on 4/20/20

15,



SEE REVERSE

OF THIS PAGE

EMPLOYEE( ) SIGNATURE

Pat

r i c k C. Doo

ley

, Inve

s t

i

ga t

o r ~

Leze t te

M. Ea rha r t , I nves t iga to r

Thomas B Smith,

g t o r

And rew

F. Sa

un de r s Inves

t

gator

W lvo r K.

Bu

t l e r , I

nves t

gato r

Ju

s t

in N. He ns on , In

ves t

i ga tor

DATE ISSUED

04/3

0/2015

1'01\, 1 FDA 483 (09/03) PREVI

OUS

ED

TION

O SOLE

TE

I

i\S

P

ECTIONAL

OBSERVATIONS

PAGE 3 OF 4 PAGES

DEP

ARTMENT

OF HEALTH AND H

UMAi\

SERVICES

FOOD

AND

DRUG ADMINJS

TRATION

OISTRtCT ADDRESS A

N

PHONE NUMBER OA TE S) OF INSPECTION

40 4 BNA Dr . Bl

dg

.

200

, Ste . 500 04/06/2015 - 04/30/2015*

FEI NVMBER

Na

s hv i

l l e

, TN 37

217

-25 97

(615 ) 3

66-

780 1 Fa x : (61

5)

3

66-

7802

10

1 9788

I ndus t r y I nfo r mat i on : www

. fda

. gov/o c / i

nd

us t ry

NAME AND Tll l .E OF INDIVIDUAL TO WHOM REPORT ISSUED

TO: Ke vin D. Woo

d,

G

ene r a l

Ma nager

FIRM NAME STREET ADDRESS

Blue Bell Creame r i e s Inc

423

N Norton Ave

C

TY

STATE ZIP C

O

E . COUNTRY TYPE ESTABLI

SHMENT

NSPECT

E

Syla

cauga

, AL 35 150 -20

09

Ma nufac tu re r

A maintenance employee, with visibly soi led arms and

shi11

was observed leaning on a package machine during production

ofNutzo

Ice Cream Cones. The employee's arms were resting on the packaging equipment and extending over exposed

product and open packaging.

OBSERVATION 6

Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility

at

any time their hands may

have become soiled or contaminated.

Specifically on 4/20/2015,

An employee was observed touching their visibly damp pant leg while wearing single-use gloves. The employee then

proceeded to load sleeves of lids on

Line during production of vanilla and chocolate ice cream without washing

hands or changing gloves.

OBSERVATION 7

The plant is not constructed in such a manner as

to

prevent condensate from contaminating food -contact surfaces.

Specifically on 4/ 10/2015,

I) The drop ceiling in the mixing room was damaged and in poor repair. Tiles appeared

to be

stained and broken

throughout the mixing room.

2) Light fixture above mixing tank had condensate on it.

OBSERVATION 8

Non food-contact equipment in manufacturing areas is not constructed so that it can be kept in a clean condition.

Specifically on

4/10/2015,

(b) 4)

I )

motor mount was rusty and had peelinglflaking paint.

b) 4)

2) Gasket for was cracked, with cracks extending from

to

outer edge

of

gasket.



DEP IHMENT

OF HEALTH AND HUM N SERVICES

FOOD ND DRUG

DM

NISTRATION

DISTRICT ADDRESS AND PHONE NUMBER DATE S) OF INSPECTION

404

BNA Dr

. ,

Bldg . 200 , Ste . 500 04/06/2015 - 04/30/2015*

FEI NUMBER

Nashvi l l e , TN 37217 - 2597

615) 366 - 7801 Fax : 615)

36 6

- 7802 1019788

Indust ry

Informa t ion : www . fda .

gov/oc / indust ry

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED

T : Kevin

D. Wood , General

Manager

FIRM

NAME STREET ADDRESS

Blue Bell Creameries

Inc

423 N Norton Ave

CITY STATE ZIP CODE

COUNTRY

Sy

la

cauga, AL 35150 -

2009

TYPE

ESTABLISHMENT I

NSPECTED

Manufacturer

DATES OF

INSPECTION:

04/06 /20

IS

Mon). 04/07/20 IS Tue), 04/08/20 15 Wed), 04/09/20 IS Thu), 04/10/20 IS Fri), 04/20/20 15 Mon). 04/

21

/20 IS Tue

,

04/29 /20 IS Wed), 04/30/20

IS

Thu)

EMPLOYEE S) SIGNATURE

Pat r i ck C. Dooley, n v e s t i g a t o r

Leze t te

M.

Earhar t

, Inve s t

i ga to r

Thomas B. Smith , Inves t iga to r

Andrew F . Saunders ,

Inves t iga to r

Wilvor K.

But le r ,

Inves t iga to r

Jus t in N.

Henson,

In ve s t i g a to r

DATE

ISSUED

04/30/20 15

FORM FDA 483 09/08) PREVIOUS

EDITION

OBSOLETE

I

NSPECTION L

OBSERVATIOl iS

PAGE 4 OF 4 PAGES

SEE REVERSE

OF THIS PAGE

n

_L

: : t \

. . . . . ~- -



The observations

o

objectionable conditions and practices listed

on

the front

o

this form are reported :

1. Pursuant to Section 704(b) of the Federal Food , Drug and

Cosmetic Act or

2 To assist firms inspected

in

complying with the Acts and

regulations enforced by the Food and Drug Administration

Section 704(b)

o

the Federal Food , Drug, and Cosmetic Act 21

USC 374(b)) provides:

Upon completion of any such inspection

o

a factory ,

warehouse, consulting laboratory, or other establishment, and

prior to leaving the premises, the officer or employee making the

inspection shall give to the owner, operator, or agent in charge a

report

in

writing setting forth any conditions or practices

observed by him which , in his judgement, indicate that any food ,

drug, device, or cosmetic

in

such establishment (1) consists in

whole or

in

part of any filthy, putrid , or decomposed substance,

or (2) has been prepared , packed, or held under insanitary

conditions whereby it may have become contaminated with filth ,

or whereby it may have been rendered injurious to health . A

copy of such report shall

be

sent promptly to the Secretary.

inspection report for blue bell, alabama

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