FDA Inspection 1034584 — Lernapharm (Loris) Inc.
The FDA completed an inspection of Lernapharm (Loris) Inc. on Dec 12, 2017 in Saint-Laurent. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 12, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint-Laurent (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |