FDA Inspection 1010153 — Aerolase Corp.
The FDA completed an inspection of Aerolase Corp. on May 3, 2017 in Tarrytown, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Tarrytown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |