Drug factory · FDA FEI 1000219637
Sterigenics U.S., LLC
10811 Withers Cove Park Dr D, Charlotte, NC, United States
No problems found at FDA's last inspection, Dec 3, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2011: 4 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gemcitabine | Sterilizes it | Janssen Biotech, Inc. | 57894-225 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 3, 2025 | No problems found | Drug Quality Assurance | — |
| Aug 26, 2019 | No problems found | Drug Quality Assurance | — |
| Jun 12, 2014 | No problems found | Drug Quality Assurance | — |
| Aug 12, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: sterilize.