FDA EIR - Cosway Company, Inc. - November 10, 2011

A routine surveillance inspection of Cosway Company, Inc., a contract manufacturer of over-the-counter (OTC) drugs and cosmetic products, was conducted by the FDA from October 26 to November 10, 2011. The inspection, performed under Compliance Program 7356.002 for Drug Manufacturing, focused on the company's quality, materials, production, and laboratory systems.

The inspection identified significant issues, most notably the firm's failure to adequately resolve and follow up on recurring out-of-specification (OOS) results, specifically concerning specific gravity tests for an Acne Spot Treatment product. This observation led to the issuance of an Inspectional Observations (FDA-483) to President and CEO, Mr. Richard L. Hough.

These current findings echoed deficiencies from a prior April 2011 inspection, which highlighted failures in change control, inadequate complaint investigation, insufficient OOS investigation, a deficient stability program, inadequate sampling and testing, and poor cleaning validation. Despite these ongoing concerns, Cosway Company, Inc. continues to manufacture a range of OTC products.

As a required action, Mr. Hough committed to implementing necessary corrections and providing a written response to the FDA's Los Angeles District by December 10, 2011. The inspection was classified as "Voluntary Action Indicated" (VAI), signifying that while objectionable conditions were found, the FDA expects the company to voluntarily undertake corrective measures.