Cosway Company, Inc. – FDA EIR, Mar 10, 2017

An FDA inspection of Cosway Company, Inc., a contract manufacturer of over-the-counter (OTC) drugs (including SPF, acne, and skin lightening products), was conducted from February 27 to March 10, 2017. The inspection, performed in accordance with 21 CFR Part 211 for drug manufacturing, identified nine significant observations documented on Form FDA 483. Main violations included a failure to thoroughly investigate unexplained discrepancies and batch failures, and inadequate complaint records that lacked investigation findings and follow-up. The firm also failed to store drug products under appropriate temperature conditions and to maintain equipment effectively to prevent product alteration. Furthermore, laboratory controls lacked scientifically sound specifications and test procedures to ensure product quality. Deficiencies were noted in the drafting, review, and approval processes for written procedures, particularly regarding component approval and the absence of a written stability testing program for drug products. Lastly, employees engaged in drug product manufacturing lacked the required training for their assigned functions. In response to these findings, the President and Chief Executive Officer committed to reviewing all observations and submitting a written response to the Los Angeles District Office within 30 days.