FDA Inspection 1026364 — Ipsen BioPharm Ltd
The FDA completed an inspection of Ipsen BioPharm Ltd on Sep 12, 2017 in Wrexham. 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 12, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wrexham (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |