Drug factory · FDA FEI 3000209996
AGC Biologics, Inc.
21511 23rd Dr SE, Bothell, WA, United States
No problems found at FDA's last inspection, May 29, 2026.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2009: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Teplizumab | Tests it | Provention Bio, Inc. | 73650-316 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 29, 2026 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 13, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.