FDA Inspection 1053903 — Merck Serono S.P.A.
The FDA completed an inspection of Merck Serono S.P.A. on May 25, 2018 in Modugno. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 25, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Modugno (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |