# FDA 483 - B & B Pharmaceuticals, Inc. - October 26, 2018

Source: https://www.keypedia.com/records/483/b-b-pharmaceuticals-inc/dd5a9431-25b6-4bda-bba3-894155ae4c60

> FDA 483 for B & B Pharmaceuticals, Inc. on October 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B & B Pharmaceuticals, Inc.
- Inspection Date: 2018-10-26
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of B & B Pharmaceuticals, Inc., an API repackager in Englewood, CO, revealed significant deficiencies in their operations. The firm demonstrated a lack of effective cleaning validation, poor batch record management, and inadequate deviation control. Furthermore, issues were identified with the independence of the Quality Unit, complaint handling, and employee training, indicating a broad failure to adhere to Good Manufacturing Practices.

## Related Documents

- [483 - 2019-11-18](https://www.keypedia.com/records/483/b-b-pharmaceuticals-inc/202502f5-0d6b-443b-9196-b2af6289bc1c)

## Related Officers

- [Jamie L. C. Dion](https://www.keypedia.com/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

Company: https://www.keypedia.com/companies/b-b-pharmaceuticals-inc/422b4ac5-c374-464f-8f90-06eacfead01e

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face