# FDA 483 - BioAccess, Inc. - April 22, 2025

Source: https://www.keypedia.com/records/483/bioaccess-inc/03af193c-d1bd-407f-be72-2424dca5ca8e

> FDA 483 for BioAccess, Inc. on April 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioAccess, Inc.
- Inspection Date: 2025-04-22
- Product Type: device
- Office Name: Baltimore District Office
- Summary: BioAccess, Inc. in Baltimore, MD, was inspected by the FDA from April 21-22, 2025. The inspection revealed that the firm's procedures for finished device acceptance were not adequately established. Specifically, the firm failed to follow its own procedures for verifying Device Master Record activities and reviewing associated documentation for several lots of small bone tools.

## Related Officers

- [Christina D. Mello](https://www.keypedia.com/people/christina-d-mello/b523622e-d2dd-4ff6-9b2b-74b3134841de)

Company: https://www.keypedia.com/companies/bioaccess-inc/68cc8373-100b-41eb-9af7-c8b60bc037f4

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa