FDA Inspection 868362 — Candela Corporation
The FDA completed an inspection of Candela Corporation on Feb 21, 2014 in Marlborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 21, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Marlborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5802 | 21 CFR 1002.13 | Lack of required elements |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |