inspection report for blue bell, alabama
TRANSCRIPT
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.
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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,
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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.
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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 \
. . . . . ~- -
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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.