FDA Inspection 1098899 — Aerolase Corp.
The FDA completed an inspection of Aerolase Corp. on August 8, 2019 in Tarrytown, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 8, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tarrytown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 5150 | 21 CFR 1040.10(f)(3) | Remote interlock connector |
| 5197 | 21 CFR 1040.10(h)(1)(i) | User information, adequate instructions |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |