FDA Inspection
Davol, Inc.Davol, Inc. – FDA Inspection, Aug 17, 2026
Record Details
This FDA Inspection record concerns Davol, Inc., with an inspection on August 17, 2026, issued by the New England District Office, covering medical devices & rad health.
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ID · 7356f808-b2ac-402b-8543-fd96db9304b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1333202
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.4Records of design and development outputs not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Davol, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 5, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Davol, Inc.
- FDA Inspection 1194306 - 2022-12-07
- FDA Inspection 1001539 - 2017-02-07
- FDA Inspection 797417 - 2012-09-05
- FDA Inspection 656851 - 2010-04-13
- FDA Inspection 652142 - 2010-03-17
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