FDA Inspection 1198107 — PFM Medical Mepro GMBH
The FDA completed an inspection of PFM Medical Mepro GMBH on Jan 26, 2023 in Nonnweiler. 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
- Jan 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nonnweiler (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 638 | 21 CFR 803.17(b)(4) | Info which facilitates timely FDA follow-up |