FDA Inspection
Avotec, Inc.Avotec, Inc. – FDA Inspection, Jan 27, 2023
Record Details
This FDA Inspection record concerns Avotec, Inc., with an inspection on January 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ec04ea29-2add-4604-bf34-889333666f71
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1196089
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Avotec, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2025 | Not classified | Florida District Office | |
| January 12, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Avotec, Inc.
- FDA Inspection 1289082 - 2025-10-28
- FDA Inspection 1037667 - 2018-01-12
- FDA Inspection 935262 - 2015-07-21
- FDA Inspection 754052 - 2011-11-15
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