Drug factory · FDA FEI 3002808536
Yung Shin Pharm. Ind. Co., Ltd.
No. 1191, Sec. 1, Zhongshan Rd., Dajia Dist., Taichung City, Taiwan
Problems found, fixed voluntarily at FDA's last inspection, Oct 22, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
14 drug inspections on record since 2010: 3 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cefaclor | Makes it | Carlsbad Technology, Inc. | 61442-171, 61442-172 |
| Cephalexin | Makes it, tests it and packages it | TWi Pharmaceuticals, Inc. | 24979-154, 24979-155 |
| Meloxicam | Makes it, packages it and labels it | Sterling Knight Pharmaceuticals,LLC | 69336-101, 69336-102 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 27, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 27, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 24, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |
| Nov 24, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 8, 2014 | No problems found | Drug Quality Assurance | — |
| May 8, 2014 | No problems found | Drug Quality Assurance | — |
| Aug 16, 2013 | No problems found | Drug Quality Assurance | — |
| Aug 16, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 30, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 30, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 5, 2010 | No problems found | Drug Quality Assurance | — |
| Feb 5, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: manufacture.