FDA WARNING_LETTER - PREMIER NUTRA PHARMA Inc. - July 08, 2022

The FDA issued a Warning Letter to Premier Nutra Pharma Inc. following an inspection from July 5-8, 2022, which revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals. The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B). Despite the firm's assertion of not being a licensed drug manufacturer, documents indicated they considered nasal sprays as OTC drug products. Key violations included the failure to thoroughly investigate unexplained discrepancies or batch failures, such as microbial contamination and the use of visibly contaminated ingredients (21 CFR 211.192). The firm also failed to establish and follow appropriate written procedures to prevent objectionable microorganisms, lacking environmental monitoring, microbiological testing, and cleaning procedures (21 CFR 211.113(a)), and failed to conduct appropriate laboratory testing for objectionable microorganisms (21 CFR 211.165(b)). Additionally, Premier Nutra Pharma Inc. failed to prepare complete batch production and control records (21 CFR 211.188) and lacked an adequate quality unit with written procedures for critical functions like batch record review, deviations, and recalls (21 CFR 211.22(a) and 211.22(d)). The FDA emphasized the firm's responsibility as a contract manufacturer for drug quality. The letter recommends engaging a CGMP consultant if the firm intends to resume drug manufacturing and acknowledges their commitment to cease production. The firm must respond within 15 working days detailing corrective actions to prevent recurrence, with potential regulatory actions for non-compliance.