FDA Inspection 1236464 — Dr Franz Koehler Chemie Gmbh
The FDA completed an inspection of Dr Franz Koehler Chemie Gmbh on Apr 11, 2024 in Bensheim. 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
- Apr 11, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bensheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |