FDA Inspection 749562 — Trillium Health Care Products Inc.
The FDA completed an inspection of Trillium Health Care Products Inc. on Sep 23, 2011 in Brockville. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brockville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |