FDA Inspection
Davol, Inc.Davol, Inc. – FDA Inspection, Feb 7, 2017
Record Details
This FDA Inspection record concerns Davol, Inc., with an inspection on February 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d05d3219-dd40-4f70-8936-56bf122a5ae6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001539
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
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Other FDA inspections of Davol, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2026 | VAI | New England District Office | Project Evaluation: Devices |
| December 7, 2022 | NAI | 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 1333202 - 2026-08-17
- FDA Inspection 1194306 - 2022-12-07
- FDA Inspection 797417 - 2012-09-05
- FDA Inspection 656851 - 2010-04-13
- FDA Inspection 652142 - 2010-03-17
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