# FDA 483 - Access Business Group LLC - June 24, 2022

Source: https://www.keypedia.com/records/483/access-business-group-llc/0f60ce53-3cbc-4752-a69e-07bd352ec940

> FDA 483 for Access Business Group LLC on June 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Access Business Group LLC
- Inspection Date: 2022-06-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Access Business Group LLC in Ada, MI, a drug manufacturer, was inspected by the FDA from June 15-24, 2022, resulting in two observations. The inspection revealed deficiencies in batch production records, which lacked complete information for critical steps, and issues with equipment storage, where portable vessels were exposed to a dusty atmosphere, posing a risk of cross-contamination.

## Related Officers

- [Constantin Y. Philopoulos](https://www.keypedia.com/people/constantin-y-philopoulos/536d53f5-7699-4b27-8b4b-10280cce9603)
- [Amanda M Dunneback, Investigator](https://www.keypedia.com/people/amanda-m-dunneback-investigator/8bb2464a-b1a2-4cff-82e2-6e5fb6583028)

Company: https://www.keypedia.com/companies/access-business-group-llc/cbbc8002-6e15-46bd-af97-65c1f7566455

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0