FDA WARNING_LETTER - Koon Cheong Lung - July 27, 2012

On July 26-27, 2012, the FDA inspected Koon Cheong Lung's food manufacturing facility in Panyu, China, and found serious violations of Current Good Manufacturing Practice (cGMP) Regulation for foods (21 CFR Part 110) and the Seafood HACCP Regulation (21 CFR Part 123). The firm's oyster sauce is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No written HACCP plan for ready-to-eat oyster sauce to control pathogen growth and toxin formation, including *Clostridium botulinum* (21 CFR 123.6(a) and (b)). 2. **Inadequate Sanitation Records:** Failure to maintain sanitation monitoring records for water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, protection from adulteration, chemical control, employee health, and pest exclusion (21 CFR 123.11(c)). 3. **Poor Production Procedures:** Raw materials on wet floor, starch bucket on open salt bag, dirty hose used for water addition, and bare-hand contact with product (21 CFR 110.80). 4. **Facility Contamination:** Condensate dripping into open steam kettle and onto raw materials