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

Cosmetic Specialty Labs, Inc. in Lawton, OK, a drug manufacturer, was inspected and cited for multiple deficiencies in its quality control and manufacturing processes. Observations included inadequate microbiological testing, deficient water system monitoring, lack of stability testing programs, unvalidated manufacturing processes, and insufficient complaint handling and annual product review procedures. These issues indicate a general lack of robust quality systems for their non-sterile topical drug products.