San-J International, Inc. – FDA Warning Letter, Sep 7, 2011

The FDA inspected San-J International, Inc., a manufacturer and co-packer of acidified soy and cooking sauces, from August 24 to September 7, 2011. The inspection revealed violations of 21 CFR Part 108 (Emergency Permit Control), Part 110 (Current Good Manufacturing Practice), and Part 114 (Acidified Foods), rendering products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. The firm did not respond to the FDA-483 issued on September 7, 2011.

Specific violations included: 1. Failure to follow the filed scheduled process, with recorded processing temperatures as low as (b)(4) and short processing times ranging from (b)(4) minutes (21 CFR 108.25(c)(3)(i)). 2. Failure to document departures from the scheduled process (21 CFR 114.89). 3. Insufficient examination of containers for acidified products prior to filling to prevent leakage or contamination (21 CFR 114.80(a)(4)). 4. Failure to calibrate instruments (chart recorder, probe thermometer) used to monitor manufacturing activities (21 CFR 110.40(f)). 5. Failure to maintain the facility in a sanitary condition and good repair, evidenced by live and dead insects