FDA Inspection 599121 — Merck Kommanditgesellschaft Auf Aktien
The FDA completed an inspection of Merck Kommanditgesellschaft Auf Aktien on Jul 2, 2009 in Darmstadt. 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
- Jul 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Darmstadt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3151 | 21 CFR 820.180 | Legibility |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |