Drug factory · FDA FEI 3000718852
FUJIFILM Diosynth Biotechnologies U.S.A., Inc
6051 George Watts Hill Drive 6040 George Watts Hill Drive, Research Triangle Park, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 21, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2010: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Efbemalenograstim Alfa | Tests it | Acrotech Biopharma Inc | 72893-016 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 21, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 9, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 31, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 16, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.