FDA Inspection 1070996 — Laboratoire Aguettant
The FDA completed an inspection of Laboratoire Aguettant on Nov 6, 2018 in Champagne. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 6, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Champagne (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |