Drug factory · FDA FEI 1545
Delta Synthetic Co., Ltd.
15, Minsheng St., Tucheng District, Taiwan
No problems found at FDA's last inspection, May 29, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lidocaine | Makes the active ingredient and tests it | MEDRx USA, Inc., Spectra Medical Deviecs, LLC | 83708-111, 65282-1605 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 29, 2025 | No problems found | Drug Quality Assurance | — |
| Oct 25, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 1, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 14, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.