FDA Inspection
Avotec, Inc.Avotec, Inc. – FDA Inspection, Jan 12, 2018
Record Details
This FDA Inspection record concerns Avotec, Inc., with an inspection on January 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4270046d-ec62-465f-a72f-e6a9624cd704
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037667
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.200(d)Service reports
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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 27, 2023 | NAI | 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 1196089 - 2023-01-27
- FDA Inspection 935262 - 2015-07-21
- FDA Inspection 754052 - 2011-11-15
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