FDA Inspection 946165 — LabAnalysis Life Science S.R.L.
The FDA completed an inspection of LabAnalysis Life Science S.R.L. on Oct 15, 2015 in Casanova Lonati. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 15, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Casanova Lonati (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |