FDA Inspection 1232702 — GlaxoSmithKline Biologicals
The FDA completed an inspection of GlaxoSmithKline Biologicals on Mar 12, 2024 in Saint-Amand-Les-Eaux. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Saint-Amand-Les-Eaux (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |