FDA WARNING_LETTER - Sincere Orient Commercial Foods Corp. - March 01, 2012

The FDA inspected Sincere Orient Commercial Foods Corp. from February 23 to March 1, 2012, identifying serious violations of Current Good Manufacturing Practice (CGMP) (21 CFR Part 110) and Acidified Food regulations (21 CFR Parts 108 and 114). These conditions render their food products, particularly "Banh Canh Vietnamese Noodle," adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to register as a commercial processor of acidified foods (21 CFR 108.25(c)(1)). 2. Failure to file scheduled processes for acidified foods, specifically "Banh Canh Vietnamese Noodle" (21 CFR 108.25(c)(2)). 3. Inadequate monitoring of finished equilibrium pH for acidified products (21 CFR 114.80(a)(2)). 4. Lack of trained supervisory personnel for acidification and critical factors (21 CFR 108.25(f)). 5. Failure to properly code acidified food containers (21 CFR 114.80(b)). 6. Absence of current product recall procedures (21 CFR 108.25(e)). 7. Employees with open lesions handling food without proper protection (21 CFR