Drug factory · FDA FEI 3003732967
Laboratoires KABS Inc
4500 rue de Tonnancour, Saint-Hubert, Canada
No problems found at FDA's last inspection, Feb 1, 2024.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2008: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abametapir | Tests it | Dr. Reddy's Laboratories Inc. | 43598-921 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 1, 2024 | No problems found | Drug Quality Assurance | — |
| Mar 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 11, 2013 | No problems found | Drug Quality Assurance | — |
| Dec 8, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 24, 2008 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 22, 2019 inspection
- Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
Registered with FDA for: analysis; manufacture.