FDA WARNING_LETTER - California Delights, Inc. - August 25, 2010

The FDA conducted an inspection of California Delights, Inc. in Newman, CA, from August 3-25, 2010, revealing significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These insanitary conditions caused the firm's food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The inspection identified four primary deficiencies. First, the firm failed to exclude pests from processing areas and protect against food contamination (21 CFR 110.35(c)), with extensive live and dead insect infestations, including larvae and excreta, found in dry storage, main kitchen, and cold storage affecting various products. Second, the grounds were not maintained to prevent contamination, with improperly stored equipment, litter, and waste near plant buildings (21 CFR 110.20(a)(1)). Third, the plant was not kept in good repair, and aisles were obstructed, preventing adequate cleaning (21 CFR 110.20(b)(4)). Fourth, utensils and equipment were not properly cleaned and sanitized, evidenced by a sink near a toilet without a partition and accumulated debris on equipment (21 CFR 110.35(a)). The firm voluntarily destroyed insect-infested products during the inspection. California Delights must promptly investigate and correct these violations, submitting a written response within 15 working days detailing corrective actions, prevention plans, and a timetable. Failure to comply may lead to regulatory actions, including product seizure or operational injunction.