DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D.'.TE(S) OF INSPECTION DISTRICT ADDRESS AND PHONE NUMBER 4040 North Central Expressway, Suite 300 Dallas , TX 75204 (214) 253-5200 Fax: (214) 253-5314 Industry Information: www.fda . gov/oc/industry 03/23/2015 - 04/23/2015* FEI NUMBER 1000118167 NAME AND TITlE OF INDIVIDUAl. TO Y'MOM REPORT ISSUED TO: Marty L Kilgore, General Manager FIRM NAME STREET ADDRESS Blue Bell Creameries, LP 8201 E Highway 51 CITY, STATE, ZIP CODE, COUNTRY TYPE ESTABliSHMENT INSPECTED Broken Arrow, OK Frozen Dair 740 14 -2900 Dessert Manufac turer This document lists observations made by the FDA representative(s) during the inspection ofyour facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. Ifyou 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) quring the inspection or submit this information to FDA at the address above. Ifyou have any questions, please contact FDA at the phone number and address above. DURING AN INSPECTION OF YOUR FIRM WE O BSERVED: OBSERV A TION 1 Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination. Specifically, you manufactured ready-to-eat, frozen, dairy desserts which tested positive for Listeria monocytogenes. The following finished product manufactured by your firm tested positive for Listeria monocytogenes. A. Institutional Chocolate Ice Cream in a 3oz cup with a pull tab lid, Lot code 041516Q, produced on 04/15/2014, tested positive for Listeria monocytogenes by the Kansas Department of Health and Environment. Your firm distributed a1IDID] 3oz cups ofthis lot between 04/ 15/2014 and 03/23/2015. produced on 03/23/2015, tested positive for Listeria lab•:>rat:o ry seJ•~cte:d by your firm. You reported you did not distribute any to your customers. B. C. Banana Pudding Ice Cream, Lot code 021217S, produced on 02/12/2015, tested positive for Listeria monocytogenes by the FDA. Your firm distribute:; . ~ PREVIOUS EDmON OBSOlETE INSPECTIONAL O BSERVATIONS 04/23/2015 PAGE I Of II PAGES DEPARTMENT OF HEALm AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DAT'E(S) OF INsPECTION DISTRICT ADDRESS ANO PHONE NUMBER 404 0 North Ce n tral Expressway, Suite 300 Dallas, TX 7 5204 (2 1 4) 253-5200 Fax: (21 4 ) 253-5314 Industry Informa tio n: www.fda.gov/oc/industry 03/23/2015 - 04/23/2015* FEINUMBER 1000118167 NAME AND 11Tl.E OF INDIVIDUAL TO WHOM REPORT ISSUED TO : Marty L Kil gore, General Manager FIRM NAME STREET ADDRESS Blue Bell Creameries, LP 8201 E Highway 51 CITY, STATE, ZIP CODE, COUNTRY TYPE ESTABUSHMENT INsPECTED Broken Arrow, OK Frozen Dairy Dessert Manufactur er 74014-2900 OBSERVATION 2 Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination. Specifically, A. B. You stated the results of your sampling for environmental pathogens on non-food contact surfaces as defined in your 04/22/2014 written procedure entitled "Plant Environmental Testing" were used as an indicator in determining whether the cleaning and sanitizing program was effective. However, this sampling program failed to include the following: a. Sampling of food contact surfaces. b. Determination ofany preventative action needed in response to the possible contamination. c. Determination ofthe impact on the products produced on the affected date. d. Determination ofthe Listeria spp. associated with the presumptive positive results. e. Root Cause Analysis of why the cleaning and sanitizing treatments were inadequate in controlling the occurrences ofmicrobiological contaminations. You also stated the results of your daily total coliform sampling on finished product, in-process product, and raw ingredients added post pasteurization were used as an indicator in determining whether the cleaning and sanitizing program was effective. However, this sampling program failed to include the foUowing: a. Determination of any corrective or preventative action needed in response to the possible contamination. b. Determination ofthe impact on the products produced on the affected date. c. Determination ofthe pathogenicity ofthe coliform isolates. d. Root Cause Analysis of why the cleaning and sanitizing were inadequate in controlling the occurrences ofmicrobiological contaminations. e. Establishment ofalert and action limits. EMPI.OYI:E(S) SIGNATURE SEE REVERSE OF THIS PAGE FORM FDA 433 (~108) ~ Lloyd D. Payne, Investigator~~ Adam C. Hipko, I nvestigator Jennifer Owens Dowdy, Investigator ~~ Franklin R. Harris, Investigator ~~~ Travis D. Brown, Investigate:~~ PREVIOUS EDntON OBSO!EI'E INSPECTIONAL OBSERVATIONS DATE ISSUED 04/23/2015 PAGB20F 11 PAGES - 0 4 / 23 /20 1 5 * 1 000 118 167 51 Br oken Ar r ow, OK 74014- 2900 Fr ozen Dai r Desse rt Ma nufacture r OBSERVATION 3 The procedure used for cleaning and sanitizing ofequipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment. Specifically, you failed to demonstrate your cleaning and sanitizing program is effective in controlling recurring microbiological contaminations. You continued to have presumptive positive environmental test results for Listeria spp. and elevated total coliform results following the daily cleaning and sanitizing treatments ofyour equipment and facilities. You reported the results of the sampling program were used as an indicator in determining whether the cleaning and sanitation program was effective. In response to presumptive positive environmental test results for Listeria spp. and the elevated total coliform counts, you reported the usual cleaning and sanitation procedures were followed and verified as being performed more thoroughly during the next cleaning and sanitizing cycle after notification ofthe results; which may b~ days for Listeria spp. and[GJIQII for in-house total coliform. Examples ofmicrobiological contamination ofproduction equipment and finished product are as follows. A. Listeria spp. was isolated from non-food contact areas within the processing room and kitchen and from non-food contact surfaces of production equipment. These included 5 samples in 2013 , 10 samples in 2014, 1 sample in January, and I sample in February of20 15. In addition, environmental samples collected by the FDA on 03/24/2015 and 03/25/2015 tested positive for Listeria monocytogenes. SEE REVERSE OF THIS PAGE FORMFDA433 Ll oyd D. Pa yne, I nvestigate Adam c. Hipko , Inves t i gato r Jenn ifer Owens Dowdy, Investigator Fr ankl in R. Harris , I nvestigato r Travi s D. Brown, Inves PREVIOUS EDITION OBSOLETE 04 /23/20 15 - 04/23/2015* 1000118 167 Creameries Broken Arrow OK LP 51 8201 E 74014- 2900 Frozen Dair Dessert Manufacturer 2/12/2015 as On 01113/2014, the (b) (4) was sampled, and the sample was sent to your 3'd party laboratory who received the samples on 01114/2014. The laboratory reported the sample from the . was presumptive positive for Listeria spp. on 01116/2014. re-sampled on 01/20/2014 and the samples were reported by the laboratory as presumptive positive for a second time on 01/23/2014. Th was documented as being cleaned and sanitized after th between 01/13/2015 and 01/17/2014, however, it failed to be cleaned and sanitized adequately and showed evidence of Listeria spp. on two consecutive samples. On 04/15/2014, at 1/2 Gallon Filler was sampled, and the sample was sent to your 3rd party who received the samples on 04/ 16/2014. The laboratory reported the sample fro~ at 1/2 Gallon Filler as presumptive positive for Listeria spp. on 04/19/2014. The ~ Gallon Filler was re-sampled on 04/22/2014 and the by the laboratory as at 1/2 Gallon Filler was presumptive positive for a second time on 04/25/2014. The documented as being cleaned and sanitized after the 15/2015 and 04/2112014, however, it failed to be cleaned and sanitized evidence of Listeria spp. on two consecutive samples. B. Total coliform greater than 20 Colony Forming Units (CFUs)/mL was identified in finished product, in­ process product batches, and raw ingredients in 6 samples during April 2014, 8 samples during January 2015, 23 samples during February 2015, and 10 samples during March 2015. You reported the Oklahoma Department of Agriculture, Food, and Forestry had a regulatory requirement of 20 CFUs/mL or less in finished products offrozen dairy desserts. , a. Your total coliform sample results greater than 20 CFUs/mL, and as high as 105 CFUs/mL, during April2014 included the following: i. On 04/15/2014, the finished product Pineapple Sherbet, Batch 117993, Lot code 04.1516S, produced on Slot . ad 33 CFUs/mL. ii. On 04/22/2014, the finished product Homemade Vanilla Ice Cream, Batch 119386, Lot code 0422160, produced on Slot iii. b. . ad On 04/25/2014, the in-process product of BBIC Vanilla in Flavor Tank . ad 105 CFUs/mL; This mix was used to produce the 3oz cups oflnstitutional Vanilla Ice Cream, . Batch 119317, Lot code 042516Q, on Slot . Your total coliform sample results greater than 20 CFUs/mL, and as high as 124 CFUs/mL during 2015 included the Lloyd D. Payne, Investigator Adam C. Hipko, Investi gato r SEE REVERSE Jennifer Owens Dowdy, Investigator OF THIS PAGE Franklin R. Harris, Investigator ~-~ Travis D. Brown, Inves fORM F1>A 483 34 CFUs/mL. · 04/23/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OATE(S) OF INSPECTION DISTRICT ADDRESS AND PliONE N\JMSER 03/23/2015 - 04/23/2015* 4040 No rth Central Expressway, Suite 300 Dallas , TX 75204 (214) 253-5200 Fax :(214) 253-5314 Industry Information: www . fda . gov/oc/industry FEJNUMBER 10001 18167 NAME ANO TITLE OF INOMOUAI. TO Y\otiOM REPORT ISSUED TO: Marty L Kilgore, General Manager FIRM NAME STREET ADDRESS Blue Bell Creameries, LP 8201 E Highway 51 CITY, STATE, ZIP CODE, COUNTRY TYFE ESTABLISHMENT INSPECTED Broken Arrow, OK 7 40 1 4-2900 i. Frozen Dairy Dessert Manufacturer On 01/12/2015, the finished product Homemade Vanilla Ice Cream, Batch 127856, Lot code 0112170, produced on Slot . ii. On 01/21/2015, the finished product Dutch Chocolate Ice Cream, Batch 129350, Lot code Ol2ll7R. produced on Slot . ad 124 CFUs/mL. Your total coliform sample results gr~ater February 2015 included the following: c. had 48 CFUs/mL. tharll CFUs/mL, and as high as 840 CFUs/mL during i. On 02/09/2015, the fmished product Dutch Chocolate Ice Cream, Batch 128824, Lot code 0209170, produced on Slot ad 275 CFUs/mL. ii. On 02/24/2015 , the in-process product ofHomemade Vanilla in Flavor Tank m. On 02124/2015, the in~process product of Homemade Vanilla in Flavor Tank had CFUs/mL; the finished product Homemade Vanilla Ice Cream, Batch 131087, Lot code 0224170, produced on Slot . ad 174 CFUs/mL. iv. On 02/26/2015, the in-process product ofHomemade Vanilla in Flavor Tank , . had 796 CFUs/mL; the finished product Homemade Vanilla Ice Cream, Batch 129403, Lot code 0226170, produced on Slot • Side . had 840 CFUs/mL in the morning and 223 CFUs/mL in the afternoon. On 02/27/2015 , the finished product Homemade Vanilla Ice Cream, Lot code 0226170, produced on Slot . ide resampled. The three samples had 25 CFUs/mL, 46 CFUs/mL, and Too Many to Count (TMC) CFUs/mL. ttl had 228 CFUs/mL; the finished product Homemade Vanilla Ice Cream, Batch 131087, Lot code 0224170, produced on Slot . had 151 CFUs/mL. 4i II awas v. d. 4i On 02/26/2015, the in-process product ofHomemade Vanilla in Flavor Tank had 392 CFUs/mL; the finished product Homemade Vanilla Ice Cream, Batch 129403 , Lot code 0226170, produced on Slot . ide . had 377 CFUs/mL in the morning and . CFUs/mL in the afternoon. On 02/27/2015, the finished product Homemade Vanilla Ice Cream, Lot code 0226170, produced on Slot . idelwas resampled. The two samples had 88 CFUs/mL and 142 CFUs/mL. Your total coliform sample results greater than 20 CFUs/mL, and as high as 121 CFUs/mL during March 2015 included the following: i. On 03 /06/2015 , the finished product Sundae Ice Cream, Batch 129531, Lot code 030617R. produced on Slot . had 67 CFUs/mL. EMPlO'tEE(S) SIGNATURE SEE REVERSE OF THIS PAGE FORM FDA 483 (09101) ~ Lloyd D. Payne, InvestigatorCT~ Adam C. Hipko , Investigator Jennifer Owens Dowdy, Investigator Franklin R. Harris, Investigator :;2 ;I{ Travis D. Brown, Investigate~ PRIMOIJS EDmON OBSOI.Eil! 0 4 /23/2015 INSP ECfi ONAL OBSERVATIONS PAGES OF II PAGES - 04/23/201 5* 1000118 1 6 7 51 8201 E Broken Arrow OK 740 14-2900 Fr ozen Oair Dessert Manufacturer ii. On 03/09/2015, the finished product Homemade Vanilla Ice Cream, Batch 129779, Lot code 030917T, produced on Slot . ad 121 CFUs/mL. iii. On 03/16/2015, the in-process product of Homemade Vanilla in Flavor Tank . ad 107 CFUs/mL; the finished product Homemade Vanilla Ice Cream, Batch 130037, Lot code 031617T on Slot 24 CFUs/mL. ~~~~~~--------------------------~ OBSERVATION 4 Failure to provide running water at a suitable temperature for cleaning of equipment, utensils and food-packaging materials. Specifically, you reported the water temperature for the washing and rinsing of the exterior surfaces of the equipment and COP . was not continuously monitored, verified, or documented. You also reported the water temperature for the CIP system used to clean and sanitize the food contact surfaces of the mix tanks, flavor tanks, freezers, fillers , and connecting pipes was not continuously monitored, verified, or documented. However, you stated the water heater was set to heat the water to a temperature between . F and . oF. The labeling on th . . sanitizer, which you use in CIP and COP procedures, states in part, " ***To CIP F water fo~inutes product lines, use • · JOUiice5 of~r one gallon of • • ounces per one gallon o~ · · . · minutes at temperature To CIP cold pr~duct storagf­ m water at . F fo. mmutes m a °F water*. . . , . should be used at a concentration of up to • • soak tank, or less time if (b) (4) ***" · (minimr;fpl On 03/3 0/2015 , you were asked to perform a check on the start-up and final water temperatures during the usual cleaning and sanitizing procedures. Following the temperature ranged from l22°F at start-up to ll8°F at final. You also 128°F. These failed to meet the instructions on you reported the CIP the COP water temperature was OBSERVATION 5 The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, and food-packaging materials. Specifically, on 03/26/2015 condensation was observed in the following areas: A. SEE REVERSE OF THIS PAGE A continual line of condensate droplets were observed along the bottom of stainless steel Product Supply These approximate!. inch diameter product lines are installed horizontally above all. LineFlavor Tanks and supply the product mixes from the basement mixing tanks. The condensate was observed dripping down onto the tops of the enclosed Flavor Tanks, however, the of enter the tanks through a hole in the top of each tank and the gaskets between the tanks an PHONE toa.IMBER DATE(S) OF INSPECTION 03/2 3/2 015 - 04/23/20 1 5* 4 0 4 0 No r th Central Expressway, Suit e 300 Dallas , TX 752 04 (214) 253- 52 00 Fax: (2 1 4) 253-5 31 4 Industry Information: www . fda . gov/o c /indu stry FEI NUMBER 1 0 00118167 NAME AND TITLE OF INOCVIOUAL TO \'\liOM REPORT ISSUED TO: Marty L Kilgore , General Manager A RM NAME STREET AOORESS Bl u e Bell Creame r i es , L P 8201 E Highway 51 C ITY, STATE. ZIP CODE, COUNTRY TYPE ESTABLISHMENT INSPECTED Broken Ar row, OK 7401 4 -2900 F r o z en Dairy Dessert Manufact urer are not tight fitting and do not prevent the entry of the condensate. Additionally, the Mix Tank Operators at Flavor Tank which contained Dutch Chocolate Supreme Ice Cream, Batch 13032 1, Lot code 032617Q, Slot · and Flavor Tank hlwhich contained Caramel Sundae Crunch Ice Cream, Batch 131906, Lot code 032617S, Slot were observed spraying the tops of the tanks with a water hose which washed the condensate into and around the gaskets and potentially contaminating the ice cream mixes in the Flavor Tanks. The ice cream mixes were post-pasteurization and "in line" to th­ freezers and packaging. The Mix Tank Operators were also observed hanging an ingredient mixing pitcher from one of the Product Supply Lines and storing other pitchers on the tops ~fthe Flavor Tanks; potentially contaminating the pitchers with condensate. #' ancfl fll B. #tl I At Flavor Tank and the Mix Draw Operator was observed removing the round tank lids and placing them directly on the top of the Flavor Tanks with the underside of the lids directly contacting condensate droplets which were dripping from Product Supply Line #s The Flavor Tanks were being used to mix Dutch Chocolate Supr eme Ice Cream, Batch 130321, Lot code 032617Q, Slot After ingredients were added to the Flavor Tanks, the Mix Draw Operator placed the lids back over the openings ofthe tanks potentially contaminating the post-pasteurized ice cream mix with condensate from the lids. 1111 ancll C. Ill Condensate was observed dripping from the Slot ~~filler Head into quart containers of Orange Sherbet, Batch 131444, Lot code 032617S, while the product was being filled and packaged between ODm] and Ill]. The production ofthe Orange Sherbet started and ended aGDBI] producing ~ uarts. aa. D. Condensate was observed dripping from Product Supply Lines 1111 ancg onto the top of cardboard cases of[ e J, ~ Gallon, Caramel Sundae Crunch Ice Cream containers which were stored directly below the lines and adjacent to Flavor Tank • The cases of containers were staged below the dripping product supply lines until needed at Slot • • which was filling and packaging Caramel Sundae Crunch Ice Cream, Batch 131906, Lot code 032617S. OBSERVATION 6 Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated. Specifically, the following instances of failure to change gloves and wash hands were observed on 03/26/201 5: A. fill the Mix Draw Operator was observed touching non-food contact and food contact At Flavor Tank surfaces with the same pair of gloved hands. The Mix Draw Operator was also observed checking the volume in Flavor Tank tflwhich contained Caramel Sundae Crunch Ice Cream, Batch 131906, Lot code 03261 7S, Slot by directly wiping product off the metal dipstick with his gloved hand, while the product drained back into the tank, and then he returned the dipstick back into the Flavor Tank. The Mix Draw Operator did not perform a hand wash or glove change prior to touching the product on the dipstick. Ill EMPLOYEE(S) SIGNATURE SEE REVERSE OF THIS PAGE FORM FDA .a3 0Ml8) ~~ Lloyd D. Payne , Investigator ~_, Adam C. Hi p ko , Investigator J e nnifer Owens Dowdy, I nvest igator Franklin R. Harris , Investigator ·;9, Travis D. Brown , I nvestigato r ~ __..,VL PRIMOUS EDmON OBSOLI!TI! DATE ISSUED _/~ tV' , 04/23/2015 INSPECTIONAL O BSERVATIONS PAGE 7 OF II PAGES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHOI£ NUMBER DATE(S) ~ INSPECTION 4040 North Centra l Expressway, Suite 300 Dallas, TX 75204 (2 1 4) 253-5200 Fax: (214) 253-531 4 Industry Information: www .fda.gov/oc/indust ry 03/23/2015 - 04/23/2015* FEINUMeER 1000118 1 67 NAME AND TITlE OF INDIVIDUAL TO WHOM REPORT ISSUED TO: Marty L Ki lgore, General Manager FIRM NAME STREET AOORESS Bl ue Bell Creameries, LP 8201 E Highway 51 CI1Y, STATE. ZlP CODE. COUNTRY 1YPE ESTABUSHMENT INSPECTED Broken Arrow , OK B. 740 1 4-2900 Frozen Dairy Dessert Manufacturer At Flavor Tank • the Mix Draw Operator and Freight Puller were observed lifting and pouring orange puree from plastic buckets into the Flavor Tank which contained Orange Sherbet, Batch 131444, Lot code 032617S, Slot The Mix Draw Operator and Freight Puller used gloved hands to pick up the buckets by the sides and bottoms while transferring from one to the other. The buckets on the bottom row were stored directly on the wet, wood pallets which had black mold-like residue and red stains. The Freight Puller was observed alternating hands while picking up the buckets by the bottom and occasionally his fmgers would contact the top rim and the inside of the puree buckets; possibly contaminating the food contact surface with the gloved fmgers which directly touched the bottom of the buckets. ttJ C. Freezer • the Machine Operator was observed rubbing the product off the ofthe filler, turning the product line valve adding chocolate chips mto the fruit feeder, making adjustments to the hairnet and hat. All of the tasks, including directly touching product to performed with the same pair o£$Ioves while pints of Chocolate Chip 132 149, Lot code 0326170, Slot fllwere being packaged. This is a repeat violation from the 2012 FDA inspection. OBSERVATION 7 Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination. Specifically, on 03/23/2015, food contact equipment used in processing and packaging including. 3oz cup fillers, packaging chutes, conveyors, and tables were observed in the basement. The area where the equipment was being stored was hot and humid due to the adjacent . All of the equipment was observed uncovered and unprotected with condensate drippmg directly onto random sections and surfaces. You reported the equipment was cleaned and sanitized after its last production run and then relocated into the basement area. You also reported the area was classified as non-sanitary and after the pieces of equipment are moved back to the roduction slot and installed, the e ui ment is sanitized rior to usa e. OBSERVATION 8 All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, you do not have cleaning and sanitizing procedures for employee shoes worn into the sanitary food production areas of the firm to ensure that any possible contamination risks are minimized. Shoes are worn out of EMf'LOYEE(S) SIGNAT\R: SEE REVERSE OF THIS PAGE FORM FDA 43 (09/08 DATE ISSUED Ll oyd D. Payne, Inves t igat or Adam C. Hipko, Investigator Jenni fer Owens Dowdy, Investigator ~ Franklin R. Harris, Investigator ~?• Travis D. Br own, Investigate£~ ~ PREVIOUS EDITION DBSOlEill INSPECTIONAL OBSERVATIONS 04/23/20 1 5 PAGES OF 11 PAGES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINlSTRATION DATE(S) OF INSPECTION DISTRICT ADDRESS AHO PHONE NUMBER 03/23/2 015 - 04/23/2015* 4040 North Central Expressway, Suite 300 Dallas , TX 75204 (214) 253-5200 Fax: (214) 253-5314 Industry Infor matio n : www.fda .gov/oc/indust ry FEI NUMBER 10001181 67 NAME AND TITI..E OF INDIVIDUAL TO WHOM REPORT ISSUED TO : Marty L Kilgore , General Manager FIRM NAME · ,. STREET ADDRESS Blue Bell Creameries, LP 8 201 E Highway 51 CITY, STATE, ZIP CODE. COUNTRY TYPE ESTABUSHMENT INSPECTED Broken Arrow, OK 740 1 4-2900 Frozen Dairy Dessert Manufacturer the firm to employee's vehicles and homes and then back into the sanitary food production areas each day without any cleaning and sanitizing requirements. In addition, employees were observed traveling from sanitary food production areas to non-sanitary areas including dry goods storage, maintenance shop, offices, break roo~ outside smoking areas, and milk truck delivery bays without cleaning and sanitizing prior to re-entry into the sanitary food production areas between 03/23/2015 and 03/27/2015. The only are located at the swinging doors of the Kitchen leading into the processing area and into the garbage collection area and in the HTST area leading into the garbage collection area. The are o~ - and do not cover tl:l.e entire distance ofthe en OBSERVATION 9 The design ofequipment does not allow proper cleaning and maintenance. Specifically, wood pallets which are porous and not easily cleanable are used throughout your firm to store and transport raw ingredients, finished product, and packaging materials. The wood pallets were observed in different stages of damage and disrepair while they were being used in the kitchen, warehouse, freezer, production, and mixing areas. The top platform, bottom, and comers ofthe pallets were broken, discolored, and soiled. The wood pallets were also observed to be saturated from being used in the wet processing areas and were observed as having black mold-like residues and red stains. The following are examples ofthe pallet usage observed on 03/26/2015: ttl· A. The Orange Plastic buckets containing Orange puree were stored on wood pallets by Flavor Tank on Slot puree was hand added as an ingredient to the pasteurized Orange Sherbet mix in Flavor Tank • • The finished product was Orange Sherbet, Batch 131444, Lot code 032617S. B. Plastic buckets containing thawed. Sliced Str!lwli-1~>1'1ri~>" Kitchen awaiting the addition ofgranulated sugar in the C. Reusable cardboard sleeves used for palletizing finished product and cardboard cases of cream containers were stored on wood aBets located in the roduction area. were stored on wood pallets in the ~ Gallon ice OBSERVATION 10 Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated. Specifically, between 04/11/2014 and 04/ 13/2014 there were several elevated temperature excursions above 45°F in unpasteurized milk products which are used as raw ingredients. These included the chocolate stored in Raw Tank iflwhicb was used in the Institutional Chocolate Ice Cream, Lot code 041516Q, produced on 04/ 15/2014. The excursions above 45°F were documented on the Lab Report and the Temperature Recorders. Examples include the following: EMPLO'IEE(S) SIGNATURE SEE REVERSE OF THIS PAGE FORM FDA 483 119108) DATE ISSUED Lloyd D. Payne, I nvestigator Adam C. Hipko, Inves t igator Jennife r Owens Dowdy, Investiga tor~ /~ Franklin R. Ha rris, Investiga tor ~~· Travis D. Brown, Investigator~~ PREVIOUS EDmON Oll$()I.I!'IE 0 4 /23/20 15 INSPECI'IONAL OBSERVATIONS PAGE 9 OF II PAGES DEPARTMENT OF HEALm AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OATE(S) OF INSPECTION OISTRICT ADDRESS AND PHONE NUMBER 4040 North Central Expressway, Suite 300 Dallas , TX 75204 (214) 253-5200 Fax : (2 1 4) 253-53 1 4 Industry Infor mation : www . fda.gov/oc/industry 03/23/2015 - 04/23/2015* FEINUMBER 1000118 1 67 NAME AND TITI.E OF INOMOUAL TO WHOM REPORT ISSUED TO: Marty L Kilgore, General Manager STREET ADDRESS ARM NAME Blue Bell Creameries, LP 8201 E Hi ghway 5 1 CITY, STATE, ZIP OODE. COUNTRY TYPE ESTABLISM.Em INSPECTED Broken Arrow, OK 74 0 14-2900 Frozen Dairy Dessert Manufacturer A. On 04112/2014, Raw Tank . as being 47°F B. On 04/12/2014, Raw Tank documented as being 46°F C. On 04/13/2014, Raw Tank . contained skim milk. The AM temperature was documented as being 48°F and the PM temperature was documented as being 46°F D. On 04/13/2014, Raw Tank . bein 50°F ntained chocolate. . The AM and PM temperatures were documented ftJ contained ~ cream. The AM and PM temperatures were contained cream rinse. The AM and PM temperature were documented as OBSERVATION 11 Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles and organic matter and the opportunity for growth ofmicroorganisms. Specifically, the stainless steel [~~a.~ mixer, referred to as th, had rough welds and non-continuous welds along the back and side splash guards located on top of the tank. The welds, approximately . inear feet in are hard to clean and create areas where food particles and microorganisms could harbor. On 03/26/2015 the Sliced Strawberries, Lot was observed being used in the Kitchen to mix granulated sugar and thawed. for the eventual addition to batches ofpasteurized ice cream mixes. OBSERVATION 12 Failure to take apart equipment as necessary to ensure thorough cleaning. Freezer . is not disassembled to thoroughly Specifically, the front face plate of the clean the white gasket which ensures there is no leakage of the ready-to-eat ice cream and sherbet. On 03/22/2015, the faceplate was removed for environmental sampling and the gasket was observed to have black mold-like residual on the flat portions ofthe gasket which forms the seal against the faceplate and the freezer body. Freezer tilwas last used in the 03/20/2015 production of the Institutional Vanilla Ice Cream in a 3oz cup with a pull tab lid, Batch 130043, Lot code 032017Q. Freezer . was reported to be "clean" following the CIP, wash, and sanitization performed on 03/20/2015. EMPLOYEE($) SIGNATURE SEE REVERSE OF THIS PAGE FORM FDA 483 (09/08) .// )/'? Ll oyd D. Payne, Investigator ,~ Adam c. Hipko, Investigat or Jenn i f e r Owens Dowdy, Investig ~ ort _;~ Fr anklin R. Harri s , Investigator ~ /Vr Tr avi s D. Br own, Invest igator .. PREVIOUS EOnlON OBSOL£11! INSPECfiONAL OBSERVATIONS DATE ISSUED 04/23/20 15 PAGE 10 OF II PAGES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OATE(S) 01' INSPECTION DISTRICT ADORES$ AND PHONE NUM8ER 4040 North Central Expressway, Suite 300 Dallas, TX 75204 {214) 253- 5200 Fax; {21 4 ) 253- 5314 Industry Information: www.fda . gov/oc/industry 03/23/2015 - 0 4/23/201 5* AOI NUM8ER 1000118167 NAME AND TITLE 01' INDIVIDUAL TO WHON REPORT ISSUED TO: Marty L Kilgore, General Manager FIRM NAME STREET ADORES$ Blue Bell Creameries, LP 8201 E Highway 51 CITY, STATE, ZIP CODE, COUNTRY TYPE ESTA8LISHME/IT INSPECTED Broken Arrow, OK 74014-2900 Frozen Dairy Dessert Manufacturer *DATES OF INSPECTION: 0312312015(Mon), 0312412015(Tue), 03125/2015(Wed), 03126/2015(Thu), 03/2712015(Fri), 03/30/20 15(Mon), 03/3 112015(Tue), 04/02120 15(Thu), 04/07/20 15(Tue), 04121/2015(Tue), 04/2312015(Thu) EMPI.OYEE(S) SIGNATURE SEE REVERSE OF THIS PAGE ... .-:--/ FORM FDA 433 (09/01) DATE ISSUED ./ Lloyd D. Payne, Investigator -A .....- - .­ Adam c. Hipko, Investigator /ioT flilf<~ Jennifer Owens Dowdy I Investigator N..t. rfT~PJ;F" Franklin R. Harris, Investigator ~ -~ Travis D. Brown , Investigat o~ PREVIOUS EDmON 08SOU!11! ' 04/23/2015 ~ ~SPECTIONAL OBSERVATIONS PAGE 11 OF 11 PAGES