FDA Inspection 958191 — Asclepion Laser Technologies Gmbh
The FDA completed an inspection of Asclepion Laser Technologies Gmbh on Jan 28, 2016 in Jena. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Jena (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |