FDA Inspection
Candela CorporationCandela Corporation – FDA Inspection, Jan 24, 2023
Record Details
This FDA Inspection record concerns Candela Corporation, with an inspection on January 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3f10d0df-2e42-4daf-a836-22d8c528cef0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195437
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
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