Drug factory · FDA FEI 3002806661
Changzhou Pharmaceutical Factory
No.518 Laodong East Road, Changzhou, China
Problems found, fixed voluntarily at FDA's last inspection, Jan 12, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Captopril | Makes it | AiPing Pharmaceutical, Inc. | 11788-135, 11788-136, 11788-137 +1 |
| Doxycycline | Makes it | AiPing Pharmaceutical, Inc., Bi-Coastal Pharma International LLC, Changzhou Pharmaceutical Factory, Cranbury Pharmaceuticals, LLC | 11788-134, 42582-216, 55488-0185 +2 |
| Levetiracetam | Makes it and tests it | Changzhou Pharmaceutical Factory, Omnivium Pharmaceuticals Llc. | 55488-0519, 81665-100, 81665-101 |
| Pregabalin | Makes it | Tris Pharma Inc | 27808-235, 27808-236, 27808-237 +4 |
| Rivaroxaban | Makes it | Changzhou Pharmaceutical Factory | 55488-0540, 55488-0541, 55488-0542 |
| Rosuvastatin | Makes it, tests it, packages it and labels it | Cranbury Pharmaceuticals, LLC | 27808-155, 27808-156, 27808-157 +1 |
| Ticagrelor | Makes it | Bionpharma Inc., Changzhou Pharmaceutical Factory | 69452-508, 69452-509, 55488-0543 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 23, 2017 | No problems found | Drug Quality Assurance | — |
| May 20, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 9, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 2, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.