FDA Inspection 1169324 — Lernapharm (Loris) Inc.
The FDA completed an inspection of Lernapharm (Loris) Inc. on May 6, 2022 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 6, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint-Laurent (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |