FDA EIR - National Vitamin Company Inc - June 09, 2022

A recent FDA surveillance inspection of National Vitamin Company, Inc. (NVC), an OTC drug manufacturer in Casa Grande, AZ, took place from June 6-9, 2022. The inspection, conducted under compliance program 7356.002 (Drug Manufacturing Inspections), focused on OTC docusate sodium and calcium softgel products. Although no FDA Form 483 was issued, several significant verbal observations were noted and discussed with management. Primary issues identified included inadequate written procedures and records for the maintenance and trending of the purified water system. Concerns were raised regarding process validation, as previous Performance Qualification (PQ) protocols for mixing and encapsulation were approved despite failing to meet target specifications or lacking complete supporting raw data. The firm's cleaning procedure for softgels was deemed deficient, notably lacking a clear definition of 'visibly clean,' which was highlighted by dried material found in a mixing tank. Additional observations included inconsistent reporting of water sampling results and the absence of an original, approved vendor evaluation form for their active pharmaceutical ingredient (API) supplier. To address these findings, NVC is required to implement robust written procedures and comprehensive record-keeping for their water system, clearly define 'visibly clean' within their cleaning protocols, and standardize laboratory reporting formats. Furthermore, the company must review and rectify deficiencies in past PQ protocols to ensure consistent production of safe and effective products, and obtain complete, approved vendor qualification documentation.