FDA Inspection 1049127 — Eurofins Biolab S.R.L.
The FDA completed an inspection of Eurofins Biolab S.R.L. on Apr 18, 2018 in Vimodrone. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 18, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vimodrone (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |