FDA Inspection 1196535 — Mt.Derm Gmbh
The FDA completed an inspection of Mt.Derm Gmbh on January 26, 2023 in Berlin. 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
- January 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |