# FDA 483 - Premier Brands Of America Inc. - May 16, 2022

Source: https://www.globalkeysolutions.net/records/483/premier-brands-of-america-inc/3fa3ae0d-ce59-4b73-b57e-0001b336165a

> FDA 483 for Premier Brands Of America Inc. on May 16, 2022. 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: 2022-05-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Premier Brands of America Inc. in Orangeburg, NY, revealed significant deficiencies in quality control and manufacturing processes for drug products. The firm failed to thoroughly investigate out-of-specification results and complete investigations within prescribed timeframes. Other issues included inadequate supplier qualification, lack of validated manufacturing processes and cleaning procedures, improper temperature monitoring, and deficient annual product reviews.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/rachael-oyewole/bc642edb-4124-4cd1-b979-0d752ead1bfd)

Company: https://www.globalkeysolutions.net/companies/premier-brands-of-america-inc/edc16d09-7daf-4279-a2d0-99df17ac18b8

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961