FDA WARNING_LETTER - Chu Minh Corp dba Chu Minh Tofu - March 27, 2012

The FDA inspected Chuminh Tofu from March 19-27, 2012, uncovering serious violations of Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110) and food labeling regulations (21 CFR Part 101). These issues render the firm's food products adulterated under Section 402(a)(4) of the Act due to insanitary conditions. Specifically, the "Chuminh Fresh and Delicious Soybean Drink, Sweetened" is adulterated under Section 402(c) for containing an undeclared and unsafe color additive (FD&C Yellow No. 5). Multiple products are also misbranded under Section 403 due to various labeling deficiencies.

Key cGMP violations included inadequate controls to minimize contamination (e.g., birds on soaking soybeans, dripping water, poor employee hygiene), improper handling of in-process food, insufficient equipment cleaning and sanitizing, and ineffective pest exclusion (rodent excreta, insects, open doors). Facility maintenance issues involved unsanitary floors, backed-up plumbing, and inadequate storage space.

Misbranding violations included incomplete ingredient lists (e.g., undeclared sugar, incorrect oil), failure to declare artificial flavorings/colorings, false or misleading nutrition information (inconsistent calorie/nutrient declarations), incorrect nutrition facts panel format (e.g., missing trans fat, cholesterol, sugars, %DV for protein, iron/calcium, improper serving sizes), and failure to repeat all required label information in both languages.

The FDA mandates a written response within 15 working days detailing corrective actions, including documentation like exterminator certifications and contamination prevention plans. Failure to implement lasting corrections may lead to regulatory actions such as product seizure, injunction, and re-inspection fees.