DEPARTMENT OF BEALmAND HUMAN SERVICES FOODANDDRUGADNUNffiTRATION asTRICT ADDRESS AAI> PHONE NUMBER DATE($) OF INSPECTION 4 0 40 North Ce ntral Expr e ssway, Suite 300 Dallas , TX 752 04 (214) 253-52 00 Fax: ( 21 4 ) 2 5 3- 5 314 Industry Info rmation : www.fda . gov/oc / i ndus t r y 03/1 6/2015 - 0 5 / 01/2015* FE! NUMBER 1 6 82009 AND TilLE OF INOMOVAL TO WHOM REPaUISSUEO TO: Pa u l W. Kruse, CEO FIRM NAME SIREETADDRESS Blue Bell Cre ame r ies , L. P . Rd OfTY, STATE, ZIPOOile, COI.JN'mV Brenham, TX 77833-441 3 Manuf acture r This document lists observations made by the FDA representative(s) dwing 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) during the inspection or submit 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 OBSERVED: OBSERVATION 1 Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms. Speci~cally, The following lots of products, which were manufactured ontiiQJ Iinellbetween 8/29/14 and 1121115 and subsequently 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 012017A, 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 line. On 2/13/15, your firm received notification from DSHS ofyour products positive for Listeria monocytogenes. Prior to resuming 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 ofthe freezer tunnel (non-food contact surface) ofthe[GJIU)lin. lin. On 2/23/15, your fum resumed operations on th4illlllin. 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 ofthese manufacturing days your ~jed routine and Hovvever, on 3/9/15, your firm found Listeria [iii)Jgenes positive swabs · • • in ~~od 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 # 030917A) were never offered :for sale. DAlE ISSUeD EMPLOVEE(S) SIGNATIJRE SEE REVERSE OFTHISPAGE Frans E. Mercado, Inve,tiqat or Hung V. Le, I n vestiga t or Danielle Lyke, I nvestigator J 813ie M. Bumpas , Investigator Haba cucV. Barrera, I n v e stiga t o r Charles B. SteiNililler, I nvestigator Fran klin R. Harris, Investig-ator Qe oise Connelly 1 Inve.stiqator Silatina J\ , Alridge, I nvli s t1gat or Massoud Motaned, Investi gator Matthew R. Maddox, I nvestigator I'REVIOOS SDITlONOBSOLETB __ _ d_.,.... .t:::J..~,.:- .., __,., fA A_ 01: 1~~ /::::/) ~~~ INSPECTIONAL OBSERVATIONS 05 /0 ~ / 2015 PAGE 1 OF4PAGES / DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DIStRICTADDRESS AND PHONE NUMI!ER DATE($) OF INSPECI'ION 4040 North Central Expressway, Suite 300 Dallas , TX 75204 (214) 253 - 5200 Fax: (214) 253-5314 Industry Information: www . f da . gov/oc/indust ry 03/16/2015 - 05/01/2015 * FEI NUIIBER 1682009 NAME AND TTT1.E OF INDIVIDUAL TO WHOM REPCRT ISSUED TO: Paul w. : Kruse, CEO FIRM NAtE : STREET ADDRESS s Blue Bell Creameries, L. P. 1101 CtlY, STAlE, 2JPCOOE, COUNlRY lYPE t<»l'ABI.ISHMENT INSP£CTEO Blue Bell Rd Brenham, TX 77833-4413 Manufacturer .~ " ~ ·:~ ~ ' ' OBSERVATION 2 The procedure used for cleaning and sanitizing ofequipment has not been shown to provide adequate cleaning and sanitizing treatment. Specifically, After shutting down·lin· for cleaning and overhaulin~EJiijJlimll on 1/30/ 15, your fum received notification from DSHS on 2/13 15 (~·positive findings ofListeria monocytogenes in y our products), your firm collected . environmental samples o • • Lintll and swabs taken at the following two locations were subsequently found posit ive for Listeria monocytogenes: Swab collected from the inside drain ofthe freezer tunnel (non-food contact surface) ofthe[GJIQ lin. on 2/19/15. Ut­ Swab collected from the outside drain ofthe freezer tunnel (non-food contact surface) ofthdtiJUJJiinejlon 2/21/15. .genes Your firm then resumed manufacturing, cleaning and sanitizing operations fortmm)linelon 2/23/15, 3/2/ 15, 3/3/15 3/ 4/l 5, 3/511 3/611 and 3/9/15. However, on 3/9/ 15, your finn fuuod Liotena pOOtive swabs line. in the bottom (food contact surface) and in the underside • • chainsprocket (food contact surface). linflwas manufacturing Sour Pop Apples ( o 030917A). However, the Sour Pop Apples (lot # 030917A) were never offered for sale. OBSERVATION 3 The plant is not constructed in such a manner as to prevent condensate from contaminating food and food-contact surfaces. Specifically, During the inspection, we observed condensate and drip throughout the facility. The following are examples of condensate EMPl.OYEE(S) SIGHA11JRE · E. Morcedo, Invo.atigator Hung V. Le1 Investigator Dan1eUe Lyke, Invest1ga1:or J amie M. Blllllpas, Investiqa1:or Ha bacuc V. Ba r rera, I nvest igator Charles B. StQinmiller, Franklin R. Harris, Inve.stigator Dani3e Connelly, Inve:.tigato.r Sil'etina R. 1\.lridge, Inve.,ti gator Massoud Hotalled, Investi<;~ator MattllGW R. Maddox, I nvestigator Fran~ · SEE REVERSE OF THIS PAGE FOR\\f FDA 483 (09198) ~ Investi<;~ator ~ /3, PREVIOUSBDmON OllSOLI!TE DATE ISSUED ~ INSPECITONAL OBSERVATIONS 05/01/2015 PAGI!20P4 PAGI!S DEPARTMENT OFBEALTHAND HUMAN SERVICES FOOD AND DRUG ADMINIS TRATION DISTRICT AOORESS AND PHONE NUMBER DATE(S) OF INSPEC110N 4040 North Central Expressway, Suite 300 Dallas , TX 752.04 (214) 253-5200 Fax: (214) 253-5314 Industry Information: www. f da.gov/oc/ ind ustry 03/16/2015 - 05/01/2015* ' : FE! NUMBER 1682009 ,. NAME ANDllllE OF INDIVIDUAL TOWHOM REPORT ISSUED TO: Paul W. Kruse, CEO ·~ ARM NAMe SlREETADDRESS s ·7· Blue Bell Creameries , L.P. 1101 CITY, STATE, ZlPCOOE, COUNTRY 1'fPE EST~T 1NSPECIED Brenham, TX Manufacturer 77833-4413 Blue Bell Rd ·~ ·~· ' that we observed dripping directly into ice cream products: On 3/17/15, we observed condensate drip on line.ocated on the 3rd floor in production areatfthe firm. The drip was falling from each ofthe!lue 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 of mint 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 area~e condensate was dripping directly into 112 gallons ofCookies 'n Cream (lot 031817H). On 4/21/15, we observed condensate drip on top ofclosed boxes ofice cream sandwich lids. The boxes containing ice cream sandwich lids were staged in the sandwich mezzanine room on the second floor ofthe firm, under stainless steel ice cream lines which feed ice cream into sandwich ;ruction lines ~he lids are an ingredient used in the manufacture ofice 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 ofthe hopper lids were caked with emulsifiers and stabilizers which had mixed with the humidity found in the room These ingredients are added to blender latong with 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 ofthe facility . OBSERVATION 5 Failure to wear beard covers in an effective manner. Specifically, EMPLOYEE{S) SlGNATIJRE Frana E. Mercado, Investigator SEE REVERSE OF THIS PAGE lfung V. Le, Investigator Dan.i elle Lyke, I nvestigator Jalllie M. BUII\pas , Investigator Habacuc V. Barrera, I nvest igator .... DAlE ISS\JED ~~ Charles B. Steinmi ller~ Invest igator Franklin R . Harris, I nvortigator ~ise Con ne lly, Inv estigat or ~ tJ f _ ~~ 05/01/201 5 Shat1na R. Alr!dqe, Investigator Ma.ssoud Motaited, Investigator Mattb.ew R. Maddox, I nvestigator FORM IDA 483 (09/08) PRBV!OUS SOITION OBSOLII'I'E ' ~ INSPECTIONAL OBSERVATIONS PAOE30F4PAGES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION ·' OISTRCTADDRESS AND PHONE NUMBER DATE(S) OF tiSPECI'ION 4040 North Ce ntral Expressway, Suite 300 Dallas, TX 75204 (214) 253-5200 Fax : (214) 253-5314 Indust ry Information : www. fda . gov/oc/industry 03/16/2015 - 05/01/2015* 1682009 ' -.~ NAM" ANDliTL.E Of INDMOIJAI. TOWHOM REPORT ISSUED TO: Paul W. Kruse, CEO ARM NAME -' SIREET ADDRESS s Bl ue Bell Rd Blue Bell Creameries, L.P. 1101 CITY, STATE, ZIP CODE, COUNTRY TYPE ESTI\Ili.ISHMENT INSPECTED Brenham, TX 77833-4413 ) FEI NOAIBER ~ .:> Manufacturer ' :;.; On 3/16/15, we observed 6 employees with beards wear protective beardnets without covering the mustache portion oftheir beards. The employees were in various areas ofthe facility, including the HTST area, and in areas where the firm was actively producing products. ' ~~ ·( !; OBSERVATION 6 Failure to maintain buildings in repair sufficient to prevent food from becoming adulterated. Hi- Specifically, On 3/16/ 15, we observed paint on the ceiling vent directly above blender& in the Blender& andlfR.oom was 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 production deep grooves, preventing the surface ofthe door guards to be easily cleaned. ar4had .. DATES OF INSPECTION: 03/16/2015(Mon), 03/l7/2015(Tue), 03/18/2015(Wed), 03/ l 9/2015(Thu), 03/20/2015(Fri), 03/30/2015(Mon), 03/3l/2015(Tue), 04/02/2015(Thu), 04/06/2015(Mon), 04/08/2015(Wed), 04/l3/2015(Mon), 04121/2015(Tue), 05/0l/2015(Fri) EMPI..OYEE(S) SIGNATURE SEE REVERSE OF THIS PAGE FORM II1>A 483 ( 09188) ....---7 Frans E. Mercado, Investi gat or flung V. Le 1 Investigat or Danielle Lyke, I nvestigator J8111ie M. Bumpas, I nvestigator Habacuc V. Barrera~ Invest igator Cbarles B. S t einmi ller, I nvestigator Fr a nklin R. Harris, lnvG::otiqator Connell y, Invest igator S a t 1na R. Al r1dge, I nvestigator Massoud Motamed, I nvest igator Matthew R. Haddox, Investigator tnise PREVIOUS EDmON DBSOI..ETB ~ ~a. DATE ISSUED ~~ INSPECI'IONAL OBSERVATIONS 05/01/ 2 015 PAGE40F4 PAOES