Drug factory · FDA FEI 3013030741
Primera Analytical Solutions Corporation
259 Prospect Plains Rd Bldg E-1 & E-2, Cranbury, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 12, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2018: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lunsotogene Parvec | Tests it | Regeneron Pharmaceuticals, Inc. | 61755-062 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 28, 2022 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| May 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.