FDA Inspection 1167881 — Niagara Pharmaceuticals Inc
The FDA completed an inspection of Niagara Pharmaceuticals Inc on Apr 25, 2022 in Dundas. 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
- Apr 25, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dundas (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |