FDA 483 - Sheng Kee of California, Inc dba Sheng Kee Bakery - March 26, 2025

Between March 11 and March 26, 2025, the FDA inspected Sheng Kee of California, Inc. (dba Sheng Kee Bakery) in Brisbane, California. The inspection identified significant safety failures under the Federal Food, Drug, and Cosmetic Act. A primary concern was the company"s inadequate hazard analysis and lack of preventive controls regarding allergens, environmental pathogens, and metal contamination. Investigators observed instances where equipment was shared among products without proper cleaning or monitoring, creating a high risk of allergen cross-contact. Furthermore, the facility suffered from a major pest infestation, with inspectors finding live beetle larvae in processing machinery and rodent droppings in production, packaging, and storage areas. Sanitation standards were consistently unmet; food-contact surfaces were cleaned without soap or sanitizer, and cooling fans were covered in residue. Personnel also failed to follow basic hygiene protocols, such as returning to food handling after touching the floor or trash without washing their hands. While these observations do not represent a final agency determination, the bakery is expected to implement corrective actions and may submit a formal response to the FDA outlining their plan to address these safety violations and improve facility compliance.