Drug factory · FDA FEI 3003674637
Qilu Pharmaceutical Co., Ltd.
No.23999, Gong Ye Bei Road, Jinan, China
No problems found at FDA's last inspection, Apr 4, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2010: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ondansetron | Makes the active ingredient | Ranbaxy Laboratories Inc. | 63304-346, 63304-347 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 4, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 9, 2018 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 25, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 1, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.