# FDA 483 - Premier Trends LLC - June 28, 2019

Source: https://www.keypedia.com/records/483/premier-trends-llc/b802191b-a9cc-4d58-b7fb-54caa62ed4f4

> FDA 483 for Premier Trends LLC on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Premier Trends LLC
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Premier Trends, a drug manufacturer in Monroe Twp, NJ, was inspected by the FDA, revealing numerous significant deficiencies across its quality, production, and laboratory systems. The inspection highlighted a severe lack of fundamental Good Manufacturing Practices, particularly concerning their Magic Heal drug product. Key issues include the absence of written procedures for critical operations, inadequate employee training, lack of equipment qualification and calibration, and insufficient product testing and stability programs.

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## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)
- [Esteban Beltran](https://www.keypedia.com/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

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

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248