FDA Inspection 1017861 — Boiron
The FDA completed an inspection of Boiron on Jul 7, 2017 in Messimy. 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
- Jul 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Messimy (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |