FDA WARNING_LETTER - Accupack Midwest, Inc. - February 27, 2024

The FDA inspected Accupack Midwest, Inc.'s drug manufacturing facility in Cincinnati, Ohio, from February 22-27, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations. The firm contract manufactures OTC drug products, including sunscreens, anti-itch creams, and analgesics.

Violations include failure to establish adequate laboratory controls (21 CFR 211.160(b)), specifically lacking appropriate specifications and testing for component water, such as limits for objectionable microorganisms, total organic carbon, or conductivity to meet Purified Water USP monograph specifications. The firm also failed to adequately monitor its water system, with noted failures in (b)(4) testing and retesting without proper investigation (21 CFR 211.192).

Additionally, the firm failed to establish written procedures for production and process control (21 CFR 211.100(a)), as processes for OTC drug products were not validated, equipment qualification was not performed on manufacturing equipment, and the water system lacked appropriate qualification.

The FDA reviewed the firm's March 18, 2024, response to Form FDA 483 and held a teleconference on June 17, 2024. Accupack Midwest has committed to temporarily ceasing drug production. The FDA recommends engaging a qualified CGMP consultant to evaluate operations, perform a comprehensive six-system audit, and