Hong Chang Corporation – FDA Warning Letter, Jul 23, 2010

On October 21, 2010, the FDA issued a Warning Letter to Hong Chang Corporation, dba California Food International, following an inspection from July 7-23, 2010, at their Santa Fe Springs, CA facility. The inspection revealed serious violations of Current Good Manufacturing Practice regulations (21 CFR Part 110), rendering food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions and potential contamination.

Key violations included: 1. **Failure to exclude pests (21 CFR 110.35(c)):** Extensive evidence of rodent excreta, urine, and gnawing was found on food products (e.g., Perilla Seeds, Soy Beans, Rice, Chili Powder), in storage areas, and on equipment. Moth-like insects and bird feces were also observed. A 1/2-inch gap at an exterior door served as a pest entry point. Although 36,814 lbs of food were voluntarily destroyed, harborage areas remained. The firm's response, including hiring a new pest control company, a janitor, and structural repairs, was deemed insufficient to eradicate pests from hidden areas. 2. **Insufficient space for sanitary operations (21 CFR 110.20(b)(1)):** Freezer (b)(4) lacked adequate space