FDA 483 - Cosmetic Specialty Labs, Inc - September 22, 2010

Cosmetic Specialty Labs, Inc. in Lawton, OK, was inspected and received a Form 483 with 10 observations primarily related to inadequate quality control and production processes for OTC drug manufacturing. The firm failed to perform analytical testing on drug products, lacked validated manufacturing processes, and had significant deficiencies in record-keeping for components, labeling, and equipment. Additionally, there were issues with component and container testing, inventory records, laboratory controls, and instrument calibration.