FDA Inspection 1119571 — Canadian Analytical Laboratories Inc.
The FDA completed an inspection of Canadian Analytical Laboratories Inc. on March 3, 2020 in Mississauga. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 3, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |