FDA Inspection 980508 — Ipsen Pharma Biotech
The FDA completed an inspection of Ipsen Pharma Biotech on July 12, 2016 in Signes. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Signes (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |