FDA WARNING_LETTER - A & M Bakery, Inc. dba Home Industry Bakery - March 27, 2013

The FDA conducted an inspection of A & M Bakery, Inc. in Clarksburg, WV, on March 15, 18, and 27, 2013. The facility, which manufactures and distributes bread, cookies, pastries, and pepperoni rolls, was found to have serious violations of the Current Good Manufacturing Practice (cGMP) regulation for foods (21 CFR Part 110). These violations render the bakery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to preparation, packing, or holding under insanitary conditions. Specific cGMP deficiencies included failure to exclude pests like flies, improper storage and use of cleaning products, and inadequate building maintenance (21 CFR 110 Subpart B). Personnel violations (21 CFR 110 Subpart A) involved employees drinking and smoking in food areas, not wearing hair/beard covers, inadequate handwashing, using soiled gloves, and storing personal clothing near manufacturing equipment. Equipment issues (21 CFR 110 Subpart C) included poorly maintained wooden tables and unmaintained seams on food contact surfaces. Additionally, the firm failed to provide safety-type bulbs over exposed food and did not store raw materials to prevent contamination (21 CFR 110 Subpart B and E). The firm is responsible for correcting these violations promptly and establishing procedures to prevent recurrence. A written response detailing corrective actions and supporting documentation is required within 15 working days. Failure to comply may lead to regulatory actions such as seizure or injunction.