Inspections, Compliance, Enforcement, and Criminal Investigations
Today's Temptations Inc. 16-Mar-05
Department of Health and Human Services
Public Health Service
March 16, 2005
RETURN RECIEPT REQUESTED
Mr. Al Filin, Owner/President
Today's Temptations, Inc.
1900 North Austin Avenue.
Chicago, IL 60639
Dear Mr. Filin:
Food and Drug Administration (FDA) investigators conducted an inspection of your bakery located at 1900 North Austin Avenue Chicago, IL 60639 on December 9, 10, 14 and 27, 2004, and documented numerous insanitary conditions which cause the food products stored there to be adulterated.
Our inspection revealed numerous deviations from the Good Manufacturing Practice (GMP) regulations, Title 21, Code of Federal Regulations (21 CFR) Part 110. At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which delineated a number of insanitary conditions present in your bakery at the time of the inspection. These conditions cause the food products stored in your bakery to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find this Act through links in FDA's homepage at www.fda.gov.
Evidence of rodent and insect activity was documented throughout your facility including: observed live mice on five different occasions; a dead mouse; and, excreta pellets on and near foods throughout your processing, packaging and storage areas. There was rodent activity found in every room within your facility. Live insects were
observed crawling on bags of flour, on and in open flour bags, and in cake mix located in the raw ingredient area, packaging, and processing rooms.
Other conditions observed during the inspection that are contributing factors to rodent and insect infestation include a hole in the center wall, five holes found in different drain pipes throughout the facility, gaps and holes under the entryway doorway to the facility, and one live mouse observed running into the rolling door jam between the entryway hall and the processing room. Also, observed were ceiling titles missing from the food processing rooms, food storage areas and packaging rooms. In the processing room in front of an oven, an insect was observed crawling on the open drain pipe extending up from the floor. These are the kinds of conditions that allow entry or harborage of pests.
The above listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence with each requirement of the Federal regulations. The investigators reported you have destroyed food products that showed evidence of contamination and began to take some steps to correct the insanitary conditions in your facility. We request that you take prompt action to correct all violations.
Please provide this office, within 15 days of receipt of this letter, a detail response stating the action you plan to take and have taken to correct and prevent the recurrence of these objectionable conditions. Provide the timeframe within which corrections will be completed, and documentation to show that corrections have been made. Failure to take prompt action to correct all violations may result in regulatory action without further notice. Such action may include, but is not limited to, seizure o injunction.
Your reply should be directed to Matthew J. Sienko, Compliance Officer, at the Chicago District Office.
Scott J. MacIntire