FDA Inspection 975165 — Niagara Pharmaceuticals Inc
The FDA completed an inspection of Niagara Pharmaceuticals Inc on May 16, 2016 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 16, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dundas (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |