FDA Inspection 1110749 — Eurofins BioPharma Product Testing Toronto, Inc.
The FDA completed an inspection of Eurofins BioPharma Product Testing Toronto, Inc. on November 15, 2019 in North York. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 15, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North York (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |