Fayus, Inc. – FDA Warning Letter, Jun 13, 2012

On September 18, 2012, the FDA issued a Warning Letter to Fayus, Inc. dba Yusol International Foods following an inspection from June 1 to June 13, 2012, of their food repacking warehouse in Sacramento, CA. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110), leading to the determination that foods at the facility were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Specifically, a filth sample of 11 subsamples from various areas of the facility showed evidence of rodent infestation and filth, including rat/mouse excreta pellets, hairs, dead moths, silverfish, and beetles. Additionally, the firm's Ground Cassava (aka "Yellow Gari") was found to be adulterated under section 402(a)(3) of the Act, as analysis of six subsamples revealed direct contact with rodent activity and filth, including excreta pellets, positive tests for xanthydrol and urea, gnaw marks, and hairs.

While the FDA acknowledged the firm's prompt actions to clean the warehouse and recondition/destroy affected Ground Cassava, specific documentation of the reconditioning procedures was not provided for evaluation. The letter emphasized that these violations are not exhaustive and that failure to correct