FDA Inspection 1142261 — Aerolase Corp.
The FDA completed an inspection of Aerolase Corp. on May 20, 2021 in Tarrytown, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 20, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Tarrytown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 5587 | 21 CFR 1005.3 | Lack of certification |