FDA Inspection 746755 — Groupe Parima Inc.
The FDA completed an inspection of Groupe Parima Inc. on Sep 13, 2011 in Saint-Laurent. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint-Laurent (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |