# FDA 483 - BAMF Health, Inc. - July 01, 2022

Source: https://www.keypedia.com/records/483/bamf-health-inc/11425191-a700-4013-8a30-4c0d38873555

> FDA 483 for BAMF Health, Inc. on July 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BAMF Health, Inc.
- Inspection Date: 2022-07-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: An FDA inspection of BAMF Health Inc. in Grand Rapids, MI, from June 27 to July 1, 2022, revealed a significant deficiency in production and process controls. The firm failed to ensure consistent production of PET drugs meeting quality standards, specifically citing inadequate environmental monitoring during aseptic manufacturing operations.

## Related Documents

- [EIR - 2022-07-01](https://www.keypedia.com/records/eir/bamf-health-inc/6a141dd0-1829-43d8-9bd6-22465ad1ba81)

## Related Officers

- [Norman K. Starks](https://www.keypedia.com/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)
- [Courtney E. Hillier](https://www.keypedia.com/people/courtney-e-hillier/4bb6ba54-896a-4296-a4ea-81d8801fdc2f)

Company: https://www.keypedia.com/companies/bamf-health-inc/a2288621-b15f-4a54-a043-64caffe33a52

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766