FDA Inspection 961402 — IPG Photonics
The FDA completed an inspection of IPG Photonics on Feb 19, 2016 in Salem, NH. 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 19, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3837 | 21 CFR 820.25(b) | Training records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |