Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 EI End: 07/24/2009
TABLE OF CONTENTS
Summary ..................................................................................................... ..................................... . I
Administrative Data .................. ................................ .................................. ...................................... 2
History .................................. ........................................... ..... ........................... ................................. . 2
Interstate Commerce ............................. ......... ....................................... ............ ................................ 2
Jurisdiction .................. ...................................................................................................................... 3
Individual Responsibility and Persons Interviewed .......................................................................... 3
Firm's Training Program ........................................................................ ................. ........ ...... ............ 3
Manufacturing/Operations ..................................................................... ..................................... ...... 3
Manufacturing Codes .......................... .............................................................................................. 6
Con1plaints ................................................................................... ........... .......................... ................ 6
Objectionable Conditions and Management's Response .................................................. ................ 7
Refusals/Samples .................... ....... ............................................................................................... .... 8
Additional Information ............................................................................ .... ................. .................... 8
Voluntary Corrections ...................................................................... .... ........................ ..................... 9
Exhibits Collected ............... ........... ......... ... ................................................ ......... .............. ................ 9
Attachments ....................................................................................... ..................... ........... ............... 9
SUMMARY
This GMP inspection of a food manufacturer was conducted perF ACTS assignment #9751 03 and
DAL-DO FY 2009 PG High Risk Food Inspections in accordance with CP 7303.803 & CP 7321.005
and covered PAC's 03803 and 21005.
The previous inspection conducted on 5/5/2005 by DSHS under FDA contract was classified as
NAI.
FDA credentials were shown by R. Todd Lorenz, CSO and Paul E. Frazier, CSO and a FDA-482
was issued to Paul W. Kruse, President and CEO on 7/23/09. The current inspection found the firm
operating as a manufacturer of various ice creams and ice cream novelties. During the inspection,
Triple caramel ice cream was covered. A field exam was conducted on Triple Caramel ice cream
and reported separately into FACTS without deviations. At the conclusion of the inspection, a l-
item FDA 483 was issued concerning condensation from an overhead caramel pipe dripping into 3
gallon tubs prior to filling and filler heads dripping condensate onto wafers for ice cream sandwiches
prior to filling. Some corrections were made and verified. There were no refusals. No samples
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 EI End: 07/24/2009
were collected during this inspection. FDA correspondence should be addressed to Paul W. Kruse,
President and CEO, President and CEO, at the address below.
ADMINISTRATIVE DATA
Inspected firm: Blue Bell Creameries Inc
Location: 1101 S Blue Bell Rd
Brenham, TX 77833-4413
Phone: 979-836-7977
FAX:
Mailing address: 1101 S Blue Bell Rd
Brenham, TX 77833-4413
Dates of inspection: 7/23/2009' 7/24/2009
Days in the facility: 2
Participants: R. Todd Lorenz, Investigator
Paul E. Frazier, Investigator
HISTORY
T he firm has been in business since 1907 and is a private corporation. The inspected facility was
first constructed in 1972. Operating hours are generally tl (4
There are about (b) 4 reduction employees at this 1ocatio~n-.-S~a...!l~
es_a_r....,
e (b) (4 wholesale and annual
volume is about b 4 gallons at this plant and t> 4 t all p ants combined. Two other
Blue Bell ice cream p ants are located in Broken Arrow, OK and Sylacauga, AL. A smaller plant is
located nearby that manufactures primarily ice cream novelties (802 Creamery St., Brenham, TX
77833). The firm has a webpage at [Link].
The previous inspection was conducted on 5/5/2005 by DSHS under FDA contract was classified as
NAI.
INTERSTATE COMMERCE
Yo of finished roducts. Milk is about rn'~% of most ice
creams and is purchased from 1:) within a ile ra~s ofthe
facility. Other ingredients such as sugar, corn syrup, cocoa, colors, & flavors originate from
interstate commerce. About >Jl"' of the finished product ice creams are shipped into ~ urrounding
states from this plant.
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 El End: 07/24/2009
JURIS DICTION
The firm operates as a food manufacturer where ingredients are from interstate commerce and
finished products are shjpped into interstate commerce. Thus, the firm is subject to 21 CFR Part 110
as well as other applicable regulations.
INDIVIDUAL RESPONSIBILITY AND PERSONS INTERVIEWED
FDA credentials were shown by R. Todd Lorenz, CSO and Paul E. Frazier, CSO and a FDA-482
was issued to Paul W. Kruse, President and CEO on 7/23/09 (Attachments 1).
Mr. Kruse identified himself as the most responsible person at the firm. Mr. Kruse is normally
present on a day-to-day basis, oversees management of production, manufacturing, and quali ty
control unit and has overall authority to detect, prevent and correct problems at the facility. This site
is also the corporate headquarters for Blue Bell Creameries, Inc. Mr. Kruse has been President &
CEO for about 5 years and reports to the Board of Directors.
Present at the discussions, accompanying us during the inspections and at the closing meeting were
Andrew (Andy) F. Kollman, Quality Control Manager and Thomas (Tommy) J. Supak, Director
Qual ity Control and Mix Operations. Mr. Kollman has been at his present position for 4 years and
with the company for 12 years. Mr. Supak and Mr. Kollman answered questions and provided
copies of requested documents. Mr. Supak has been with the firm for 35 years. Both report directly
to Mr. Kruse. Organizational charts and contacts were collected as Exhibit 2.
FIRM'S TRAINING PROGRAM
All new employees undergo training in GMP, hand washing and sanitation, and food handling via
classroom instruction and videos. New refresher videos and coursework are provided on a periodic,
at leas {5) (-4 basis.
MANUFACTURING/OPERATIONS
The firm operates as a manufacturer of numerous ice cream flavors and sizes as well as and ice
cream novelties such as cones and ice cream sandwiches. This facility manufactures about PJ
{15) (4). allons annually. The other two Blue Bell facilities located in Broken Arrow, OK an
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 EI End: 07/24/2009
Sylacauga, AL produce abou (15) (4) gallons. A list of all products manufactured at this site was
collected as Exhibit 3.
The facility occupies about D .4::1- square feet of manufacturing, staging, storage, warehousing, and
freezer space in a single freestanding building. Floors are concrete with drains within the
manufacturing areas. There are load-out docks for shipping out finished products and receiving raw
materials. A floor plan of the facility was collected as Exhibit 4 .
gallon refrigerated silos dedicated
. . _.........._._ol:-'
allons. Milk tankers are dedicated
The firm is aware of allergen issues and utilizes sequencing as well as full clean outs after nut
allergens. Mini Country Cones contain peanuts. Egg yolks are ingredients for French Vanilla ice
cream and Chocolate Moo-llenium Crunch. Nuts used in ice creams include; pecans, almonds,
walnuts, eanuts and macadamia nuts. Nuts are received fro (o) (4)
t) .4::1- and 4
Analysis are required for nut acceptance with tests conducted or b) 4
~~~------------
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 EI End: 07/24/2009
........_._,_......___, An exam le Certificate of Analysis and Bill of Lading for a recent shipment of roasted
almond from tJ 4 was collected as Exhibit 10. All ingredients are inventoried and
used on a FIFO (first in first out) basis. Chocolate wafers for ice cream sandwiches are made in a
separate kitchen area and consist of primarily flour, sugar, and chocolate powder.
The firm utilizes HACCP concepts with CCP ' s a (15) 4
pasteurization time and temperature. The {B) {lr) r-ar~e-h
,_a_v_e_m
- oru
-.,...to-r"'"in-g-,-v-e"""
ri""'
fi-c-
at"'"io_n/
..,....
va ""'l~
idation
and recordkeeping.
sis and
The three largest volume ice creams are and (15) (4) Popsicles
are also manufactured on separate dedicated lines. During the inspection on 7/23/09 production of
the following ice creams was observed; Pecan Pralines n cream, Strawberry, Banana Nut; Groom 's
Cake, Vanilla, Cookie Cones, Nutty Chocolate, Rocky Road, low fat vanilla ice cream, Triple
Caramel and Ice Cream Sandwiches.
During the inspection on 7/23/09, a stainless steel pipe conveying liquid caramel was observed
directly over the 3 gallon filler station for Triple Caramel ice cream lot '072311 A'. Condensate had
collected on the pipe and about 1 drop of condensate per minute was observed falling into the empty
3 gallon cartons just prior to filling and packaging (Exhibit 6).
In addition, condensate was observed on the fillers above (t> (4 ice cream sandwich machines. A
drop of condensate was observed fall ing onto a sandwich wafer on one of the machines from the
filler pipe located directly above it j ust prior to fi lling and packaging Jot '072311 G' (Exhibit 7).
These observations were noted on the FDA 483 issued at the closing meeting on 7/24/09.
Employees were observed wearing hairnets or hats, gloves, uniform shirts and aprons where
appropriate. Hand wash stations in production rooms as well as employee rest rooms were inspected
and had adequate hot 1d towels. The firm utilizes Brenham City sewer services and
Brenham City water. e tested (15) (4) and used for outdoor cleaning and milk truck
washouts.
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833 -4413 EI End: 07/24/2009
anitizer
Pest control is contracted to{ ) (4) and administered by on
B)l2JJ Pest control records were reviewed for the previous 6
months. Tin cats, insect light traps and insectacutors, bait stations and catchalls with glue boards
were observed in various areas of the plant and perimeter of the building. There were no
observations noted for pests.
A field exam was conducted on Triple Caramel ice cream and reported separately into FACTS
without deviations. An ingredient list for Triple Caramel ice cream was collected as Exhibit 9.
MANUFACTURING CODES
The Broken Arrow, OK plant uses letters ' Q, R, S, and T' exclusively as the last digit of the lot code.
The Sylacauga, AL plant uses letters 'W, X, Y and Z' exclusively as the last digit of the lot code.
COMPLAINTS
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 EI End: 07/24/2009
There were no recent complaints in FACTS to follow-up. The firm has a procedure for documenting
and investigating complaints.
OBJECTIONABLE CONDITIONS AND MANAGEMENT'S RESPONSE
Present at the closing meeting on 7/24/09 with myself and Paul E. Frazier, CSO were; Paul W.
Kruse, President and CEO, Andrew F. Kollman, QC Manager, Thomas J. Supak, Director QC and
Mix Supervisor, Stacy L. Thiel, QC Supervisor, Kim Grei ffenstein, Production Supervisor, and
Eugene C. Supak, Vice President-Operations.
A l-item FDA 483 was issued to Paul W. Kruse, President and CEO and discussed in detail. I
informed management that the written item was our inspectional observations and upon further
review by the Agency, the conditions listed may or may not be considered violations of the FD&C
Act. The legal sanctions available to FDA were explained should the conditions be considered
violations and remain uncorrected.
I also informed Mr. Kruse and management that my inspection may not have encompassed all
processes or area of the plant. It was explained that their firm was responsible for maintaining the
proper GMP requirements appropriate for their operations.
I explained that the firm could direct a response letter of the observations directly to the District
Director of DAL-DO, preferably within 10 days. Mr. Kmse stated that they intended to correct all
observations noted and would send a response letter documenting the modifications that were made.
[A CC response letter from Mr. Kruse was received at AUS-RP on 8/4/09) .
Observations listed on form FDA 483
OBSERVATION 1
All reasonable precautions are not taken to ensure that production procedures do not contribute
contamination from any source.
Specifically, on 7/23/09 a stainless steel pipe conveying liquid caramel was located directly over the 3 gallon fi ller
station for Triple Caramel ice cream lot '0723 1J A'. Condensate had collected on the pipe and about I drop of condensate
per minute was observed fall ing into the empty 3 gallon cattons just prior to filling and packaging.
In addition, condensate was observed on the fillers above 6frJ ice cream sandwich machines. A drop of condensate was
observed falling onto a sandwich wafer on one of the mac mes from the filler pipe located directly above it just prior to
filling and packaging lot '072311 G'.
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 El End: 07/24/2009
Reference: 21 CFR 110.80
Supporting Evidence and Relevance: Exhibits 7-8, condensation falling into a food product or
container is adulteration.
Discussion with Management: Mr. Kruse agreed with the observations and gave assurances that the
line to the 3 gallon filler would be rerouted such that condensate could not drip into containers.
Additionally, Mr. Kruse noted that the firm's mechanics installed stainless steel shrouds with
sanitary welds around the fillers of all ice cream sandwich machines the evening of7/23/09. This
correction was verified on 7/24/09 prior to closing.
Mr. Kruse stated that the fitm was finnly committed to following GMP's and these observations
were helpful to the QC team to improve their systems and means of detection of other problems that
might occur.
It was also discussed at the closing meeting that the drop down plastic curtain at the entrance to the
production room was a possible source of contamination and not easily cleanable. Mr. Kruse agreed
and stated another solution such as a quick-open door would be incorporated immediately.
Employee practices were discussed; it was emphasized that employees may occasionally need
reminders and retraining concerning good handling practices at ice cream filling stations. Mr. Supak
stated that employee practices were a constant struggle but on the job training was consistently
emphasized. There were no further comments or questions and the inspection was closed.
REFUSALS/SAMPLES
There were no refusals. No samples were collected during this inspection.
Paul E. Frazier, CSO participated in the entire inspection and took the photographs for this report.
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc EI Start: 07/23/2009
Brenham, TX 77833-4413 El End : 07/24/2009
VOLUNTARY CORRECTIONS
The firm installed stainless steel shrouds with sanitary welds around the fillers of all ice cream
sandwich machines the evening of 7/23/09. This correction was verified on 7/24/09 prior to closing.
EXHIBITS COLLECTED
1. Interstate shipping documents (14 pages).
2. Org charts (8 pages).
3. Product listing (9 pages).
4. Floor plan of facility (1 page).
5. Ice cream tlow process diagram (1 page).
6. Photos of caramel pipe with condensation over empty 3 gallon tubs prior to filling (2 pages).
7. Photos of condensation above ice cream sandwich filler (2 pages).
8. Photo of SS shroud on filler of ice cream sandwich filler (1 page).
9. Ingredient list for Triple Caramel Ice Cream (I page).
I 0. C of A and B/L from D o4 (2 pages).
11. FDA 525 with CD of photos taken during inspection ( 1 page).
ATTACHMENTS
1. FDA 482 issued to Paul W. Kruse, President and CEO on 7/23/09.
2. One item FDA 483 issued to Paul W. Kruse, President and CEO on 7/24/09.
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Establishment Inspection Report FEI: 1682009
Blue Bell Creameries Inc El Start: 07/23/2009
Brenham, TX 77833-4413 El End: 07/24/2009
Paul E. Frazier, Investigator
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