FDA Inspection
BioAccess, Inc.BioAccess, Inc. – FDA Inspection, Apr 22, 2025
Record Details
This FDA Inspection record concerns BioAccess, Inc., with an inspection on April 22, 2025, issued by the Baltimore District Office, covering medical devices & rad health.
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ID · e9bb63b6-e4c4-4600-8c13-15fa98f9afdf
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1267578
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
1- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of BioAccess, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 17, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioAccess, Inc.
- FDA Inspection 1246993 - 2024-08-20
- FDA Inspection 993631 - 2016-11-17
- FDA Inspection 656896 - 2010-04-13
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