Drug factory · FDA FEI 3004485164
Sterling Wisconsin, LLC
W132n10550 Grant Dr, Germantown, WI, United States
No problems found at FDA's last inspection, Mar 12, 2024.
No Action Indicated: inspectors found no objectionable conditions.
12 drug inspections on record since 2009: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrite Ion and Thiosulfate Ion | Makes the active ingredient | Hope Pharmaceuticals | 60267-812 |
| Thiosulfate Ion | Makes the active ingredient | Hope Pharmaceuticals | 60267-705 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 12, 2024 | No problems found | Drug Quality Assurance | — |
| Mar 12, 2024 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 4, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 4, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 4, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 4, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; particle size reduction.