FDA Inspection 1170224 — ITM Medical Isotopes GmbH
The FDA completed an inspection of ITM Medical Isotopes GmbH on November 11, 2020 in Garching B. Munchen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 11, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Garching B. Munchen (Germany)
Additional Details
Mutual Recognition Agreement (MRA)