FDA WARNING_LETTER - jer-vic inc., - January 31, 2008

On January 29 and 31, 2008, an FDA inspection of Jer-Vic Inc., dba Foy's Pigeon Supplies, revealed serious violations of the Federal Food, Drug, and Cosmetic Act. The firm repackaged, relabeled, and distributed Foy's Baytril Liquid, an unapproved new animal drug, rendering it unsafe under section 512(a) and adulterated under section 501(a)(5) of the Act.

Significant deviations from current Good Manufacturing Practice (cGMP) regulations (21 C.F.R. Parts 210 and 211) were identified, causing the drug product to be adulterated under section 501(a)(2)(B). Specific cGMP violations included: - Failure to verify the identity of each component, including Enrofloxacin, prior to repackaging (21 C.F.R. § 211.84(d)(1)). - Failure to test each component for purity, strength, and quality, including Baytril (enrofloxacin), prior to repackaging (21 C.F.R. § 211.84(d)(2)). - Failure to establish separate or defined areas or other control systems of adequate size to prevent contamination or mix-ups, lacking a dedicated repackaging area (21 C.F.R. § 21