Little Moon Essentials, LLC – FDA Warning Letter, Jan 18, 2024

On September 17, 2024, the FDA issued a Warning Letter to Little Moon Essentials, LLC, following an inspection from January 16-18, 2024, at their Dania Beach, FL facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm relied on supplier COAs without verifying identity, purity, strength, and quality of raw materials, including APIs. They also lacked a supplier qualification program and did not ensure water suitability for drug manufacturing. The response was deemed inadequate for not detailing how component quality would be ensured or providing a retrospective assessment. 2. **Failure to test finished drug products (21 CFR 211.165(a)):** The firm did not perform analytical and microbiological release testing for each batch of OTC topical drug products prior to distribution. The response was inadequate for not providing sufficient evidence of how finished products would meet quality standards or a detailed risk assessment for distributed products. 3. **Failure to establish written production and process control procedures (21 CFR 211.100(