FDA EIR - Cosway Company, Inc. - June 18, 2013

An FDA abbreviated surveillance inspection of Cosway Company, Inc., a contract manufacturer of Over-The-Counter (OTC) drugs, was conducted from July 9-11, 2013. The inspection, performed under Compliance Program 7356.002 (Drug Manufacturing Inspections), focused on the company's Quality and Packaging/Labeling systems for products like sunscreen, skin lightening cream, and acne treatments. Cosmetics were excluded.

The inspection resulted in an FDA Form 483, Inspectional Observations, primarily for the company's failure to adequately document investigational findings for product complaints. This observation echoes a similar issue from a previous FDA inspection in November 2011, which also cited a failure to document conclusions and follow-up in investigation records. The report noted that the firm's operations had not changed since the prior inspection.

The FDA classified the inspection as Voluntary Action Indicated (VAI). In response, Mr. Bruce H. Farrell, Director of Quality Services, committed to providing a written response to the District within 30 calendar days addressing the observations. The company is current in its annual drug registration.