BioAccess, Inc.April 22, 2025

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

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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.

Company: BioAccess, Inc.
Inspection Date: April 22, 2025
Product Type: Device
Office: Baltimore District Office
Person: Christina D. Mello

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ID · 03af193c-d1bd-407f-be72-2424dca5ca8e