FDA WARNING_LETTER - Velocity Pharma LLC - November 12, 2010

The FDA issued a Warning Letter to Velocity Pharma LLC following an inspection of their dietary supplement contract manufacturing and packaging facility in November 2010. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies included the firm's failure to verify finished product specifications for identity, purity, strength, and composition, and to conduct identity testing for dietary ingredient components prior to use. The company also failed to adequately identify and trace packaging and labels, maintain complete batch production records, and keep required records for returned dietary supplements, receiving, and equipment. Further violations involved the absence of specific instructions in Master Manufacturing Records, inadequate precautions to prevent contamination, and a lack of written procedures for holding and distribution. Additionally, the firm did not have temperature/humidity recording devices in its warehouse, failed to record label receipt dates, and used unqualified equipment. Velocity Pharma LLC must respond within fifteen working days, detailing specific corrective actions and timelines to address these systemic quality system failures, or face potential product seizure or operational injunction.