FDA WARNING_LETTER - Premium Production LLC - February 08, 2019

On February 6-8, 2019, the FDA inspected Premium Production LLC, identifying serious Current Good Manufacturing Practice (CGMP) violations for dietary supplements under 21 CFR Part 111. These deficiencies render the firm's dietary supplement products adulterated per 21 U.S.C. § 342(g)(1). The inspection revealed a systemic failure to establish and implement critical written procedures and documentation across various operations. Specifically, the firm failed to establish and implement product specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.70, 111.73, 111.75), and written quality control procedures (21 CFR 111.65). Further violations included the absence of written master manufacturing records (21 CFR 111.210), inadequate batch production records, and a lack of written procedures for packaging and labeling operations, product complaint handling, and holding and distribution. The firm's February 20, 2019, response to the FDA-483 was deemed inadequate as it lacked supporting documentation for the promised corrective actions. Premium Production LLC must promptly correct these violations and notify the FDA in writing within fifteen working days, providing specific steps, recurrence prevention plans, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and the assessment of reinspection fees.