# FDA 483 - Premier Brands of America Inc. - November 21, 2025

Source: https://www.globalkeysolutions.net/records/483/premier-brands-of-america-inc/7ee4eaa5-ca16-4471-9f0d-db9c2186f496

> FDA 483 for Premier Brands of America Inc. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Premier Brands of America Inc.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Premier Brands of America Inc in Hudson, NY, an OTC repacker/relabeler, revealed significant deficiencies in drug product storage conditions. The firm failed to conduct temperature mapping studies for warehouse areas storing raw materials and finished goods, and lacked adequate temperature monitoring controls. These issues raise concerns about the identity, strength, quality, and purity of OTC drug products requiring specific storage conditions.

## Related Officers

- [Tanya R. Syffrard](https://www.globalkeysolutions.net/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)

Company: https://www.globalkeysolutions.net/companies/premier-brands-of-america-inc/27ca3ffb-62da-4c8c-9a3a-468b417e7567

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d
