Drug factory · FDA FEI 1000208912
Quality Packaging Specialists International, LLC
2030 Route 130 N, Burlington, NJ, United States
No problems found at FDA's last inspection, May 12, 2023.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 6 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadolinium Cation (3+) | Labels it | Bayer HealthCare Pharmaceuticals Inc. | 50419-325 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 12, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 3, 2017 | No problems found | Drug Quality Assurance | — |
| Dec 17, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 27, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 17, 2011 | No problems found | Drug Quality Assurance | — |
| Sep 24, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.