FDA EIR - Cosway Company, Inc. - October 27, 2023

An FDA inspection of Cosway Company, Inc., a contract manufacturer of topical Over-The-Counter (OTC) drug products, was conducted from October 25-27, 2023. This follow-up inspection, initiated due to a consumer complaint, focused on the firm's Quality and Laboratory Systems, consistent with Compliance Program 7356.002 for Drug Manufacturing Inspections. The inspection revealed two significant observations documented on a Form FDA 483. First, the company lacked appropriate controls over computer systems. Specifically, an unvalidated Excel spreadsheet used for storing and generating stability data for OTC drug products lacked an audit trail and security controls, allowing unauthorized data modification and enabling approval signatures to precede preparation signatures on formal reports. Second, the firm failed to thoroughly investigate unexplained discrepancies, particularly numerous Out-Of-Specification (OOS) temperature and humidity readings in stability chambers housing OTC drug products. These excursions were recorded but not formally investigated, and issues like an exposed probe and slightly ajar chamber doors were noted. In response, Cosway Company's Chief Operating Officer, Mr. Gregory V. Chambers, acknowledged the observations and committed to providing a written response within 15 business days. The firm indicated plans to transition to a validated Laboratory Information Management System (LIMS) by January 2024 to address the data integrity issues and immediately rectified physical issues with the stability chambers during the inspection.