FDA Inspection 891189 — Merck Serono S.P.A.
The FDA completed an inspection of Merck Serono S.P.A. on Jul 1, 2014 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 1, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Modugno (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |