FDA Inspection 1117142 — Niagara Pharmaceuticals Inc
The FDA completed an inspection of Niagara Pharmaceuticals Inc on Feb 7, 2020 in Dundas. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 7, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dundas (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |