Drug factory · FDA FEI 2000021110
CSPC Ouyi Pharmaceutical Co., Ltd.
No.88 Yangzi Road, Economic and Technological Development Zone, Shijiazhuang, China
Problems found, fixed voluntarily at FDA's last inspection, Sep 5, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2012: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Azithromycin | Makes it, makes the active ingredient, tests it and packages it |
Precision Dose Inc., Slate Run Pharmaceuticals, LLC., TAGI Pharma, Inc. |
68094-690, 68094-799, 68094-900 +6 |
| Benzonatate | Makes it and tests it |
Rising Pharma Holdings, Inc. |
64980-634, 64980-635 |
| Bupropion | Makes it |
Epic Pharma, LLC |
42806-348, 42806-349 |
| Carbamazepine | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
0832-6022, 0832-6023, 0832-6024 |
| Celecoxib | Makes it |
Mullan Pharmaceutical Inc., Westminster Pharmaceuticals, LLC |
83301-0011, 83301-0012, 83301-0028 +2 |
| Clopidogrel | Makes it |
Megalith Pharmaceuticals Inc |
71717-101 |
| Esomeprazole | Makes it and tests it |
CSPC Ouyi Pharmaceutical Co., Ltd., Rising Pharma Holdings, Inc. |
24075-0700, 24075-1701, 64980-632 +1 |
| Gabapentin | Makes it, tests it and packages it |
Megalith Pharmaceuticals Inc, Mullan Pharmaceutical Inc., Precision Dose Inc., TAGI Pharma, Inc., Westminster Pharmaceuticals, LLC |
71717-102, 71717-103, 83301-0001 +13 |
| Levamlodipine | Makes it, makes the active ingredient, tests it and packages it |
CSPC Ouyi Pharmaceutical Co., Ltd., Wraser Llc, Xspire Pharma, Llc |
24075-0411, 24075-0413, 66992-425 +3 |
| Meloxicam | Makes it |
Belcher Pharmaceuticals,LLC |
62250-676 |
| Metformin | Makes it, tests it and packages it |
Megalith Pharmaceuticals Inc, Mullan Pharmaceutical Inc., Precision Dose Inc., TAGI Pharma, Inc. |
71717-104, 71717-105, 71717-106 +13 |
| Tramadol | Makes it |
Cranbury Pharmaceuticals, LLC |
27808-301 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Sep 5, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 20, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 2, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 25, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 18, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 26, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 3, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 15, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture; pack.