FDA Inspection 1237962 — Guerlain
The FDA completed an inspection of Guerlain on Apr 26, 2024 in Chartres. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 26, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chartres (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |