FDA WARNING_LETTER - Chan Yee Jai - March 06, 2013

The FDA inspected Chan Yee Jai's food facility in Hong Kong on March 5-6, 2013, and found serious deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). The firm's food products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. The FDA investigator issued an FDA-483, and the firm stated no corrections would be made.

Violations include: lack of backflow protection in piping systems (21 CFR 110.37(b)(5)); absence of sanitary hand drying devices (21 CFR 110.37(e)(3)); use of non-cleanable wooden equipment and utensils (21 CFR 110.40(a)); failure to protect against contamination from foreign substances (21 CFR 110.10(b)(9)), such as cardboard over exposed food and plastic tape on a noodle machine; inadequate pest protection (21 CFR 110.20(b)(7)) with unscreened windows and flies; failure to prevent contamination from production procedures (21 CFR 110.80) due to workers eating on processing tables; buildings not maintained in sufficient repair (21 CFR 110.35(a)) with peeling paint over food