FDA Inspection 1092542 — GlaxoSmithKline Vaccines Srl
The FDA completed an inspection of GlaxoSmithKline Vaccines Srl on Jun 6, 2019 in Sovicille. 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). 11 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Sovicille (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 9449 | 21 CFR 610.18(b) | Seed lots |