FDA EIR - Cosway Company, Inc. - September 06, 2024

An FDA routine surveillance inspection of Cosway Company, Inc., a cosmetics manufacturer located in Carson, CA, was conducted from September 4-6, 2024. The inspection, performed under Compliance Program 7329.001, focused on cosmetic manufacturing operations. While no FDA Form 483 was issued, the inspection identified three key areas requiring attention. Main issues included a failure to exclude pests from the facility, evidenced by a six-inch door gap observed in the Reeves Building. Additionally, personnel practices were found to be inadequate, as employees were seen wearing jewelry on the production floor during manufacturing. Finally, the company's website contained a misleading statement claiming FDA licensing, a term the FDA does not use. Cosway Company, Inc. committed to several required actions: repairing the door gap by October 31, 2024; implementing a new Standard Operating Procedure prohibiting jewelry on the production floor and training employees by September 30, 2024; and correcting the inaccurate website statement by September 30, 2024. These measures are necessary to ensure compliance with regulatory standards for facility maintenance (21 CFR 117.35(c)) and personnel hygiene (21 CFR 117.10).