FDA Inspection
Candela CorporationCandela Corporation – FDA Inspection, Oct 18, 2011
Record Details
This FDA Inspection record concerns Candela Corporation, with an inspection on October 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Candela Corporation
- Inspection Date
- October 18, 2011
- Product Type
- Devices
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ID · 95a32ff5-99a6-4186-bc5e-e49078bd5854
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752274
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 1002.13Failure to submit
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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 8, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 21, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Candela Corporation
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