FDA Inspection 1015497 — Opella Healthcare International SAS
The FDA completed an inspection of Opella Healthcare International SAS on Jun 23, 2017 in Compiegne. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Compiegne (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |