FDA Inspection 1332822 — Rommelag CDMO GmbH
The FDA completed an inspection of Rommelag CDMO GmbH on Mar 20, 2025 in Sulzbach-Laufen. 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). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 20, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sulzbach-Laufen (Germany)
Additional Details
Mutual Recognition Agreement (MRA)