DEPARTMENT OF HEALTH AND HUMAN SERV ICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NVMBER DATE(S) OF INSPECTION 04/06/2015 - 04/30/2015* 404 BNA Dr ., Bldg . 200 , Ste. 500 Nashville , TN 37217-2597 ( 615) 366-7801 Fax: (615) 366- 7802 Industry Informat i on: www . fda . gov/oc/industry FEINUMBER 1019788 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO : Kevin D. Wood, General Manager F IRM NAME STREET ADDRESS Blue Bell Creameries Inc 423 N Norton Ave CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT IN SPECTED Sylacauga, AL 35150-2009 Manufacturer 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 determ ination regarding your comp liance. 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 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 INSPECTI ON OF YOUR FIRM WE OBSERVED: OBSERVATION 1 Failure to perform microbial testing where necessary to identify possible food contamination. Specifically, You stated the results of your sampling 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 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. 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 on the line during production of Bride's Cake Ice Cream. The employee, who was not dressed in the appropriate Blue Bell outer garment, was wearing a shirt which appeared soiled and with several holes. 1li SEE REVERSE OF THIS PAGE FQR)1 F DA 483 (09108) ~1- Patrick c. Dooley, Investigato~t~ Lezette M. Earhart, Investigator Thomas B. Smith, Investigator Andrew F. Saunders, Investigator Wilvor K. Butler, Investigator Justi n N. Henson , Investigator EMPLOYEE($) SIGNATURE PREVIOUS EDITION OBSOLETE - ' f . /.)ott/} ' ~~ ~,:1)\ INSP ECTIONAL OBSERVATIONS DATE ISSUED 04/30/2015 PAGE I OF 4 PAGeS DEPARTMENT OF HEALTH AND H UMAI'i SERVICES FOOD AND DRUG ADMINISTRATION DATE(S) OF INSPECTION DISTRICT ADDRESS AND PHONE NUMBER 404 BNA Dr ., Bldg . 200, Ste. 500 Nashville, TN 37217-2597 (615) 366 - 7801 Fax : (615) 366 - 7802 Industry Information : www.fda . gov/oc/industry 04/06/2015 - 04/30/20 15* FE.INUMBER 1019788 NAME AND mLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO : Kevin D. Wood, General Manager FIRM NAME STREET AOORESS Blue Bell Creameries Inc 423 N Norton Ave C ITY, STATE, ZIP CODE, COUNTRY TYPE ESTABLISHMENT 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 observed in an employee hand sink immediately following the The equipment was stored in the sink while a COP tank was available for adequate approximately from the sink. and gaskets were line after production. of equipment 2) On 410/2015, the . .. used in the chocolate blending room, was stored in a unclean metal milk can between and pump was dirty and was located directly over the storage container. uses. The hose connecting the Ill Ill OBSERVATION 4 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 half ofthe tool. The tool was being used to on Cone Line ~ 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 ofMooo Bars. 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, EMPLOYEE(S) SIGNATURE SEE REVERSE OF THIS PAGE FORM FDA 483 (09108) fW Patrick c. Dool ey, Investigator Lezette M. Earhart , Investigator Thomas B. Smith, Investigator Andrew F. Saunders, Investigator Wilvor K. Butler, Investigato r Justin N. Henson, Investigator PREVIOUS t,DmON OBSOLETE INSPECTIONAL OBSERVATIONS DATE ISSUED 04/30/20 15 PAGE 2 OF 4 PAGES DE PARTMENT OF H EALTH AND HUMAi\ SERV ICES FOOD AND DRUG ADMINJSTRATION OA TE(S) OF INSPECTION OISTRtCT ADDRESS AND PHONE NUMBER 40 4 BNA Dr., Bl dg . 200 , Ste . 500 Na s h v i lle , TN 37 217 -25 97 ( 6 15 ) 3 66- 780 1 Fa x : ( 61 5) 3 66- 7802 I n dust r y I nfo r mat i on : www .fda . g ov/oc / i ndust ry 04/06/2015 - 04/30/2015* FEI NVMBER 101 9788 NAME AND Tlll.E OF INDIVIDUAL TO WHOM REPORT ISSUED Ke vin D. Wo o d, General Ma n a ger TO: FIRM NAME STREET ADDRESS Blue Be ll Creame ries Inc 423 N Norton Ave C ITY, STAT E, ZIP CODE . C OUNTRY TYPE ESTABLISHMENT INSPECTED Syla cauga , AL 35 1 50 -20 09 Ma nufacturer 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-wash ing 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 washin g 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/ 10/2 015 , I) The drop cei ling 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 II 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) 2) Gasket for motor mount was rusty and had peelinglflaking paint. (b)(4) was cracked, with cracks extending from ­ EMPLOYEE($) SIGNATURE SEE REVERSE OF THIS PAGE 1'01\,"1 FDA 483 (09/0 3) DATE ISSUED Pat ri c k C. Doo ley , Inve st i gat or p~ Lezette M. Earh art , I nvestigator Thomas B . Smit h, I nve st ~ gator An d rew F. Saunders, Inves ti gator Wil vo r K. Bu t l er, I nves tigato r Ju stin N. He n s on , Investi ga tor PREVIOUS EDITION OBSOLETE to outer edge of gasket. Ii\SP ECTIONAL O BSERVATIO NS 0 4/3 0/2015 PAGE 3 OF 4 PAGES DEPAIHMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADM INISTRATION DATE(S) OF INSPECTION DISTRICT ADDRESS AND PHONE NUMBER 404 BNA Dr ., Bldg . 200 , Ste . 500 Nashville , TN 37217 - 2597 (615) 366 - 7801 Fax : (615) 366 - 7802 Industry Informa t ion : www . fda . gov/oc/industry 04/06/2015 - 04/30/2015* FEI NUMBER 1019788 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO : Kevin D. Wood , General Manager STR EET ADDRESS FIRM NAME Blue Bell Creameries Inc 423 N Norton Ave CITY, STATE, ZIP CODE , COUNTRY TYPE ESTABLISHMENT INSPECTED Sy la cauga, AL 35150 - 2009 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 SEE REVERSE OF THIS PAGE FORM FDA 483 (09/08) ~ _L : : t/\ r ~ n Patrick C. Dooley, Investigator ~'""-- · - ...,...~ Lezette M. Earhart , Invest igator ~ Thomas B . Smith , Investigator Andrew F . Saunders , Investigator Wilvor K. Butler, Investigator Justin N. Henson, In ve stigator PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIOl'iS DATE ISSUED 04/30/20 15 PAGE 4 OF 4 PAGES The observations of objectionable conditions and practices listed on the front of 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 enfo rced by the Food and Drug Administration Section 704(b) of the Federal Food , Drug, and Cosmetic Act (21 USC 374(b)) provides : "Upon completion of any such inspection of 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."