The Federal Drug Administration (FDA) recently issued a warning letter to SnugZ USA, Inc. following an inspection at its facility where sunscreen products are manufactured. The FDA said that the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to current good manufacturing practice.
During inspection, investigators observed specific violations including, failure to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, for each batch of drug product required to be free of objectionable microorganisms and appropriate laboratory testing as necessary. Products included Naawk Aloe Relief Gel + Lidocaine, Unscented SPF 30 Sunscreen Lotion, and Coconut Breeze SPF 50.
FDA has requested that the company provide:
- Procedures for testing all finished drug dosage products according to the specifications.
- Completed chemical and microbial analytical method validation, equipment validation, and updated test methods. Provide specifications that the drug products must conform to before a batch disposition decision.
- A summary of test results obtained from testing retain samples of all drug products within expiry that have been distributed in the United States.
The FDA also contends the company failed to adequately test incoming active pharmaceutical ingredients and other raw materials used in manufacturing drug products to determine the conformance to identity, purity, strength, and other specifications. Lastly, they said the firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.