FDA 483 - Cosmetic Specialty Labs, Inc - November 18, 2013

Cosmetic Specialty Labs, Inc. in Lawton, OK, a drug manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The observations highlight a lack of appropriate laboratory testing, inadequate procedures for preventing objectionable microorganisms, and an absence of validated processes and stability programs for its non-sterile drug products. These issues indicate a failure to ensure the identity, strength, quality, and purity of its drug products.