FDA 483 - Dee Cee Laboratories, Inc - September 13, 2019

An FDA inspection of Dee Cee Laboratories, Inc. in White House, TN, revealed significant deficiencies in their manufacturing and quality control processes for OTC drug products. The firm failed to validate manufacturing processes, investigate batch failures and customer complaints, and conduct adequate finished product and in-process testing. These observations indicate a lack of robust quality systems necessary to ensure drug product identity, strength, quality, and purity.