FDA WARNING_LETTER - Sheng Kee of California, Inc dba Sheng Kee Bakery - August 31, 2023

The FDA inspected a bakery manufacturing and distributing facility in Brisbane, CA, from August 14-31, 2023, revealing significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The facility's ready-to-eat (RTE) and non-RTE bakery products were deemed adulterated due to insanitary conditions.

Key violations include the failure to prepare and implement a comprehensive food safety plan, lacking a written hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures. Specifically, the facility did not identify and evaluate allergens (e.g., egg, soy, wheat, milk, sesame, peanuts, tree nuts) as hazards requiring preventive controls, leading to undeclared egg in mooncakes and a product recall. Environmental pathogens like Salmonella were not identified as hazards for RTE products, and environmental monitoring was not performed. Mycotoxins were not evaluated as a hazard for ingredients like wheat, soy, and tree nuts, and no supply-chain program was in place.

Further violations included inadequate pest exclusion (flying insects, spiders observed), poor personnel practices (personal belongings in production areas, unwashed hands), insufficient cleaning of non-food contact surfaces, improper storage of food and ingredients (on floors, in contact with dirty electrical cables), and facility not constructed for adequate cleaning (black residue on