FDA Inspection 1179634 — GlaxoSmithKline Biologicals
The FDA completed an inspection of GlaxoSmithKline Biologicals on Sep 13, 2022 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Saint-Amand-Les-Eaux (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |