FDA EIR - Cosway Company Inc - April 08, 2011

An FDA inspection of Cosway Company Inc., a contract manufacturer of cosmetics and over-the-counter (OTC) drug products, was conducted from March 28 to April 8, 2011. This routine surveillance inspection, carried out under the regulatory framework of CPGM 7356.002, assessed the company's quality, production, and laboratory systems pertaining to OTC sunscreen, skin lightening, and acne treatment products. The inspection resulted in a "Voluntary Action Indicated" (VAI) classification, signifying objectionable conditions that warrant attention. An FDA-483, Inspectional Observations, was issued detailing several significant issues. Main violations included a failure to adequately follow change control procedures, insufficient investigation and documentation of complaints, and a lack of proper investigation into out-of-specification results in drug batches. Additionally, the inspection identified an inadequate stability program, an insufficient sampling and testing plan, and deficient cleaning validation. Notably, many of these issues were similar to those cited in a previous 2010 inspection. In response to the observations, Cosway Company Inc. committed to providing a written response to the district within 30 days.