FDA Inspection
PATHPATH – FDA Inspection, Nov 17, 2025
Record Details
This FDA Inspection record concerns PATH, with an inspection on November 17, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a2f5df87-43b0-4be6-a364-16231a2aae55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1291616
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of PATH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 17, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for PATH
- FDA Inspection 1253984 - 2024-10-18
- FDA Inspection 1014974 - 2017-05-17
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