FDA EIR - Cosway Company, Inc. - February 24, 2023

An FDA surveillance inspection of Cosway Company, Inc., an over-the-counter (OTC) drug and cosmetic contract manufacturer located in Carson, CA, was conducted from February 16 to February 24, 2023. This cGMP (current Good Manufacturing Practices) inspection, focusing on OTC drug manufacturing per Compliance Program Guidance Manual 7356.002, identified two significant observations. Firstly, the company's laboratory controls were found deficient, specifically regarding the lack of scientifically sound and appropriate test procedures. Critical equipment used for testing finished OTC drug products, including sunscreens and acne treatments, was not qualified, a fact acknowledged by the firm's R&D and Stability Managers. This raises concerns about the reliability of product identity, strength, quality, and purity testing. Secondly, a repeat observation from a previous 2017 inspection, drug products were not stored under appropriate temperature conditions. Documentation showed warehouse temperatures at the Fordyce and Reeves locations frequently exceeded 90°F, reaching up to 100°F, without adequate cooling methods or corresponding temperature excursion studies to justify these conditions. Such excursions could compromise product integrity. At the inspection's conclusion, a two-item Form FDA 483, Inspectional Observations, was issued to Mr. Gregory V. Chambers, COO, who committed to providing a written response to the FDA within 15 business days detailing the firm's corrective actions. The required actions involve qualifying laboratory equipment and implementing effective temperature controls and studies to ensure compliant product storage.