FDA Inspection 934049 — GlaxoSmithKline Manufacturing S.P.A.
The FDA completed an inspection of GlaxoSmithKline Manufacturing S.P.A. on May 27, 2015 in Torrile. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 27, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Torrile (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |