Drug factory · FDA FEI 3001174523
Standard Chem. & Pharm. Co., Ltd. Plant II
No. 154, Kaiyuan Rd., Tainan City, Taiwan
No problems found at FDA's last inspection, Nov 4, 2022.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2011: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupivacaine and Epinephrine | Tests it | Hospira, Inc. | 0409-1541, 0409-3812, 0409-4208 +3 |
| Pitavastatin | Makes it and tests it | Upsher-Smith Laboratories, Inc. | 0832-6048, 0832-6049, 0832-6050 |
| Riluzole | Makes it | Florida Pharmaceutical Products, LLC. | 69076-200 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 4, 2022 | No problems found | Drug Quality Assurance | — |
| Dec 8, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 7, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 6, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 23, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.