# FDA 483 - B & B Pharmaceuticals, Inc. - November 18, 2019

Source: https://www.keypedia.com/records/483/b-b-pharmaceuticals-inc/202502f5-0d6b-443b-9196-b2af6289bc1c

> FDA 483 for B & B Pharmaceuticals, Inc. on November 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B & B Pharmaceuticals, Inc.
- Inspection Date: 2019-11-18
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of B&B Pharmaceuticals, Inc. in Englewood, CO, an A/I repackager and distributor, revealed two repeat observations concerning significant deficiencies in their quality system. The firm lacked established specifications for primary packaging material review and release, and their product quality reviews were insufficient, failing to identify critical stability information. These repeat findings indicate persistent quality control issues.

## Related Documents

- [483 - 2018-10-26](https://www.keypedia.com/records/483/b-b-pharmaceuticals-inc/dd5a9431-25b6-4bda-bba3-894155ae4c60)

## Related Officers

- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

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