FDA Inspection 1024520 — MEDA Manufacturing GmbH
The FDA completed an inspection of MEDA Manufacturing GmbH on September 7, 2017 in Cologne. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cologne (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |