Premier Trends LLC – FDA Warning Letter, Sep 29, 2021

The FDA inspected Premier Trends LLC's drug manufacturing facility from September 23-29, 2021, identifying significant CGMP violations for finished pharmaceuticals, rendering their "Magic Heal" drug product adulterated and misbranded. The product is considered a drug due to its intended use as a skin protectant.

Key violations include: 1. **Lack of finished product testing:** Failure to test Magic Heal for identity and strength of active ingredients (e.g., dimethicone) and lack of approved specifications. 2. **Inadequate component testing:** Failure to test incoming raw materials like dimethicone, neem oil, and karanja oil for identity, strength, purity, and quality, and relying on supplier Certificates of Analysis without validation. 3. **Uncalibrated equipment:** Failure to calibrate or verify the accuracy of manufacturing equipment (e.g., temperature-controlled (b)(4) and scales). 4. **Inadequate production records:** Lack of complete master and batch production records, including approval signatures, detailed instructions, equipment identity, sampling, and yield, with unapproved changes to manufacturing processes. 5. **Insufficient personnel training:** Failure to ensure personnel, including the co-owner performing manufacturing, are qualified and adequately trained in CGMP operations. 6. **Absence of a Quality Control Unit:** Lack of a functional Quality Unit with defined responsibilities and procedures for batch release, manufacturing processes, deviations