FDA WARNING_LETTER - Mai's Bakery Corp - March 28, 2011

The FDA inspected Mai's Bakery, Corp in Monterey Park, CA, from March 22-28, 2011, revealing serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110. These deficiencies render the firm's dessert products, including Mochi and Moon Cakes, adulterated per Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations include failures in storing raw materials to prevent contamination, maintaining utensils in sanitary condition, handling work-in-progress to protect against contamination, and properly maintaining containers. The inspection also cited inadequate cleaning of non-food-contact surfaces and insufficient hand-washing facilities. Management failed to ensure employee hygienic practices, such as proper hand washing, glove maintenance, use of hair/beard covers, and confining beverages. Additionally, the firm failed to properly identify and store toxic materials and used sanitizing agents (chlorinated bleach) at unsafe concentrations. A critical finding was the failure to control conditions to minimize microbial growth (21 CFR 110.80(b)(2)), as several ambient-temperature products like Mung Bean Mochi and Rainbow Cake were found to support rapid growth of undesirable microorganisms. FDA recommends refrigerating or reformulating these products. Mai's Bakery must take prompt corrective action and respond in writing within 15 working days, detailing steps taken and providing a timetable for any outstanding corrections. Failure to comply may lead to regulatory actions, including product seizure or injunction.