Kwong Tung Foods, Inc. – FDA Warning Letter, Dec 18, 2014

On November 17-20, 24, and December 18, 2014, the FDA inspected Kwong Tung Foods, Inc., a manufacturer of egg noodles, wheat noodles, rice noodles, and sprouts. The inspection revealed serious violations of 21 CFR Part 110 (CGMP). Samples collected showed extensive rodent evidence, including excreta pellets, hair, gnawing, and urine, as well as live and dead drugstore beetles in mung bean seeds and flour. This led to the determination that the firm's food products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. Failure to exclude pests (21 CFR 110.35(c)), with numerous observations of rodent excreta, dead mice, and live/dead insects throughout the facility and on equipment. 2. Failure to properly store and dispose of rubbish to minimize pest attraction (21 CFR 110.37(f)), evidenced by gnawed ingredient bags and used flour bags acting as harborage. 3. Failure to maintain gloves in a sanitary condition (21 CFR 110.10(b)(5)), as employees re-used uncleaned single-service gloves. 4. Failure to wear suitable outer garments (21 CFR 110.10(b)(