FDA Inspection 1040770 — Les Entreprises Stefmar Inc.
The FDA completed an inspection of Les Entreprises Stefmar Inc. on Jan 18, 2018 in Saint-Jerome. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 18, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint-Jerome (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |