FDA WARNING_LETTER - Quality Liquid Feeds, Inc - July 25, 2014

On July 24-25, 2014, an FDA inspection of Quality Liquid Feeds, Inc. in Menomonie, Wisconsin, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for licensed medicated feed manufacturers (21 CFR Part 225). The firm also limited access to records and refused photography, constituting a denial of inspection under section 501(j) of the FD&C Act, causing medicated feeds to be adulterated.

Specific violations included: - Refusal to provide interstate commerce records for Type A medicated articles. - Refusal to allow access to or review of the complaint file. - Refusal to permit photography of the facility, including Type A medicated article storage conditions. - Failure to properly identify, store, handle, and control drugs (21 CFR 225.42(b)(4)): observed leaking liquid onto medicated articles, wet and stained bags, removed lot codes/expiration dates from open bags, unprotected open bags, cracked medicated article container, and expired medicated article. - Failure to maintain accurate daily drug inventory records (21 CFR 225.42(b)(6)): discrepancies between inventory and physical counts for multiple medicated articles, and unrecorded transfers. - Failure to maintain a clean and orderly building (21 CFR 225.20(b)(2)): pooled water and