FDA Inspection 892490 — Eurofins BioPharma Product Testing Czech Republic S.R.O.
The FDA completed an inspection of Eurofins BioPharma Product Testing Czech Republic S.R.O. on Jul 29, 2014 in Brno-Jih. 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
- Jul 29, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brno-Jih (Czech Republic)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |