FDA Inspection 1161983 — Lasetech LLC
The FDA completed an inspection of Lasetech LLC on Feb 10, 2022 in Lawrenceville, NJ. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 10, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lawrenceville, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |