FDA Inspection 802081 — Merck Serono S.P.A.
The FDA completed an inspection of Merck Serono S.P.A. on Sep 25, 2012 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
- Sep 25, 2012
- Fiscal Year
- 2012
- 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 |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |