FDA Inspection 1015351 — Pharmetics (2011) Inc.
The FDA completed an inspection of Pharmetics (2011) Inc. on June 22, 2017 in Laval. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 22, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Laval (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3566 | 21 CFR 211.84(c)(4) | Composite sample top/middle/bottom |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |