Inspections, Compliance, Enforcement, and Criminal Investigations
Barney's Weir Cove Bakery 09-Aug-04
Department of Health and Human Services
Public Health Service
Baltimore District Office
August 9, 2004
RETURN RECEIPT REQUESTED
Mr. George M. Barney
Barney's Weir Cove Bakery
1242 Pennsylvania Avenue
Weirton, WV 26062
Dear Mr. Barney:
On May 10-12, 2004, the Food and Drug Administration (FDA) conducted an inspection of your firm located at 1242 Pennsylvania Ave., Weirton, WV. The inspection revealed significant deviations from FDA's Current Good Manufacturing Practice requirements for foods, Title 21, Code of Federal Regulations (CFR), Part 110. At the conclusion of the inspection, you were issued a Form FDA-483, Inspection Observations, which delineated a number of gross insanitary conditions present in your bakery at the time of the inspection. These conditions cause the bakery products manufactured in your facility to be adulterated within .the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). You can find this act at www .fda.gov/opacom/laws .
The following is a list of the insanitary conditions observed by our investigator during the inspection, referenced to the Current Good Manufacturing Practice regulation for human foods, Title 21, Code of Federal Regulations, Part 110:
Effective measures are not being taken to exclude pests from the processing area and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). During the inspection, our investigator observed live insects in, on and around food processing equipment and raw materials.
Failure to maintain equipment, containers, and utensils used to convey food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7) and failure to maintain buildings, fixtures or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). During the inspection, our investigator observed an accumulation of dough and flour inside, on and near food processing equipment. Furthermore, our investigator observed live insects crawling on this accumulation of dough and flour.
Personnel working in direct contact with food, food-contact surfaces, and food-packaging materials failed to conform to hygienic practices to protect the food against contamination, as required by 21 CFR §110.10(b). Specifically, during the inspection employees were observed, processing dough against a soiled apron, placing dough on non-food contact surfaces, processing dough without any type of hair restraint, and employees eating and drinking in the food processing areas.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to assure that all of your products are in compliance with the Act. You should take prompt action to correct these deviations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence. Your response should outline the specific things that you are doing to correct these deviations. You should include in your response documentation and written verification procedures or other useful information that would assist us in evaluating your corrections. If you cannot complete 'all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your response should be sent to the Food and Drug Administration, Attention: Steven B. Barber, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions regarding this letter, please contact Mr. Barber at (410) 779-5134.