FDA Inspection
MICROspecialties, Inc.MICROspecialties, Inc. – FDA Inspection, Jun 17, 2026
Record Details
This FDA Inspection record concerns MICROspecialties, Inc., with an inspection on June 17, 2026, issued by the New England District Office, covering medical devices & rad health.
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ID · 8ae9212f-22f1-4be9-9568-4ea69eb2f809
Inspection Facts
- Inspection number
- 1322428
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.3.3Design and development inputs not determined
- ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
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Other FDA inspections of MICROspecialties, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2025 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 4, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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