# FDA WARNING_LETTER - Premier Trends LLC - September 29, 2021

Source: https://www.keypedia.com/records/warning_letter/premier-trends-llc/d95f5ac2-ca7d-4cb6-a2ad-f3a2d196e366

> FDA WARNING_LETTER for Premier Trends LLC on September 29, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Premier Trends LLC
- Inspection Date: 2021-09-29
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: 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

## Related Documents

- [483 - 2019-06-28](https://www.keypedia.com/records/483/premier-trends-llc/b802191b-a9cc-4d58-b7fb-54caa62ed4f4)
- [483 - 2021-09-29](https://www.keypedia.com/records/483/premier-trends-llc/21f30ad0-b4af-4629-aeb5-1e007ce8d242)

## Related Officers

- [Deputy District Director](https://www.keypedia.com/people/craig-w-swanson/7fddeef9-fb53-48ba-afc2-80e15d7f777f)

Company: https://www.keypedia.com/companies/premier-trends-llc/66aba88a-42bd-43a9-a2bb-4920791d6f6a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02