FDA Inspection
Candela CorporationCandela Corporation – FDA Inspection, Feb 8, 2017
Record Details
This FDA Inspection record concerns Candela Corporation, with an inspection on February 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5c86fe6-1829-4cdc-8d77-b4d4bc367f1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002942
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.86Acceptance status
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Other FDA inspections of Candela Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2017 | Not classified | New England District Office | |
| February 21, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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