Accupack Midwest Inc – FDA EIR, Jun 17, 2016

Accupack Midwest Inc. underwent an FDA Good Manufacturing Practices (GMP) inspection from June 13-17, 2016, as an over-the-counter (OTC) drug manufacturer and repacker. This inspection, conducted under CPGM 7356.002 and 7356.002B, resulted in a nine-item FDA Form 483, detailing significant and, in many instances, recurring violations of regulatory standards.

Key issues included a fundamental lack of authority within the Quality Control Unit, which failed to perform final reviews of OTC batch records, leading to numerous errors such as missing signatures, dates, and out-of-specification product weights. The firm also lacked essential written procedures for managing deviations, change controls, and conducting comprehensive Annual Product Reviews.

The water system used in manufacturing was found to be unvalidated, without adequate monitoring or testing protocols. Critically, the company failed to recognize and address historical out-of-specification results for water quality, continuing to use non-compliant water.

Further violations involved deficiencies in material control, specifically in verifying supplier Certificates of Analysis and using unvalidated in-house methods for identity testing of raw materials. Inappropriate storage of OTC products alongside industrial chemicals also posed a contamination risk.

Process and equipment validation were notably absent; manufacturing processes for pain relief cream, SPF 30 sunscreen, and antibacterial hand sanitizer repackaging remained unvalidated, alongside a lack of in-process controls and qualification for automated equipment. Finally, the firm had insufficient stability data for its OTC products and was found distributing items with incorrect manufacturing codes.

Management acknowledged the observations and committed to providing a written response, indicating the necessity for substantial corrective actions to bring operations into compliance with FDA regulations.