Jennifer C. Ellis
President and CEO
Cosmetic Specialty Labs, Inc.
210 SW Texas Ave.
Lawton , OK 73501-8128
United StatesFEI 1622491Issued Feb 29, 2024Division of Pharmaceutical Quality Operations II
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1622491.
Violations7
Issue DateFeb 29, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Cosmetic Specialty Labs, Inc.
Location
Jennifer C. Ellis
President and CEO
Cosmetic Specialty Labs, Inc.
210 SW Texas Ave.
Lawton , OK 73501-8128
United States
FEI Number
1622491
Country
United States
Issue Date
February 29, 2024
Issuing Office
Division of Pharmaceutical Quality Operations II
Product Type
Drugs
Status
Open
Summary
Cosmetic Specialty Labs, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter drug products including pain relievers, hand sanitizers, and sunscreens. The company's quality control unit failed to establish adequate oversight and ensure drug products met established specifications for identity, strength, quality, and purity, rendering the products adulterated. Additionally, at least one drug product was not properly listed with the FDA as required by law, making it misbranded and prohibited from interstate commerce. The violations were identified during an FDA inspection conducted in September 2023 at the facility in Lawton, Oklahoma.
Cosmetic Specialty Labs, Inc. FDA Warning Letter, February 29, 2024