FDA Inspection 1118070 — Rommelag CDMO GmbH
The FDA completed an inspection of Rommelag CDMO GmbH on February 18, 2020 in Sulzbach-Laufen. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 18, 2020
- Fiscal Year
- 2020
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Sulzbach-Laufen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |