FDA Inspection 912269 — Boiron
The FDA completed an inspection of Boiron on Jan 30, 2015 in Montevrain. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montevrain (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |