LS Promotions Inc. – FDA Warning Letter, May 2, 2024
The FDA inspected LS Promotions Inc. (FEI 3002657228) from April 24 to May 2, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.
Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a) and 211.165(b)):** The firm did not adequately test OTC drug products (SPF 15 lip balm, SPF 30 sunscreen, hand sanitizer) for identity, strength of active ingredients, or microbiological contamination before release. Required actions include providing chemical and microbial specifications, an action plan and timeline for testing retain samples of all in-expiry distributed batches, and a summary of results with rapid corrective actions if substandard.
2. **Inadequate stability testing program (21 CFR 211.166(a)):** The firm lacked sufficient stability data to support assigned shelf-lives for their drug products, especially for liquid products and the SPF 15 lip balm with added ingredients. Required actions include a comprehensive CAPA plan for the stability program, including stability-indicating methods, studies for each product in its marketed container, an ongoing program, detailed attribute testing, and updated procedures.
3. **Failure to establish adequate production and process controls (21 CFR 21
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