FDA Inspection 980565 — Merck Serono S.p.A.
The FDA completed an inspection of Merck Serono S.p.A. on May 10, 2016 in Modugno. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Modugno (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |