FDA WARNING_LETTER - Italian Rose Garlic Products, Inc - August 30, 2011

An FDA inspection of Italian Rose Garlic Products, Inc. in Riviera Beach, FL, conducted from August 17-30, 2011, revealed significant violations of federal regulations for acidified food products (21 CFR 108 and 21 CFR 114). The firm's acidified food products are deemed adulterated under sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the failure to process products in conformity with the scheduled process (21 CFR 108.25(c)(3)), specifically by shipping products before completing a required hold period, exceeding maximum safe pH levels, and not determining equilibrium pH prior to shipment. Furthermore, the firm failed to comply with 21 CFR 114.89, which mandates specific actions when process deviations occur, such as reprocessing or evaluation. A third violation involved the failure to change lot codes often enough for proper identification, particularly for products manufactured across multiple personnel shifts, as required by 21 CFR 114.80(b). The FDA requires a written response within fifteen working days detailing specific corrective actions and preventative measures to address these serious quality system and compliance issues. Failure to promptly correct these violations may lead to enforcement actions, including product seizure or injunctions.