FDA 483 - Cosway Company, Inc. - February 24, 2023

During an inspection conducted from February 16-24, 2023, the U.S. Food and Drug Administration (FDA) identified significant concerns at Cosway Company, Inc., a contract manufacturer located in Carson, CA. The inspection highlighted two primary issues. First, the firm's laboratory controls lacked scientifically sound and appropriate test procedures. Specifically, critical Research and Development laboratory equipment used for testing finished over-the-counter (OTC) drug products, including Murad Acne Control Clarifying Cream Cleanser, was found to be unqualified. This deficiency was confirmed by the firm's R&D and Stability Managers. Secondly, drug products were not stored under suitable temperature conditions. Cosway Company, Inc. failed to investigate numerous temperature excursions, reaching 90-100°F, recorded in their warehouses throughout 2021 and 2022. These excursions impacted retained OTC drug products and raw materials designated for OTC drug manufacturing, which require storage below 77°F. These observations, documented on an FDA Form 483, indicate deviations from expected good manufacturing practices for drug products. While not a final determination of compliance, the company is required to review these findings and promptly implement corrective actions to ensure product identity, strength, quality, and purity, or provide objections to the FDA.