Drug factory · FDA FEI 3008338784
Procaps S A
CALLE 80 78 B 201, Barranquilla, Colombia
No problems found at FDA's last inspection, Apr 28, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2009: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dronabinol | Makes it, packages it and labels it | Akorn | 17478-761, 17478-762, 17478-763 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 28, 2023 | No problems found | Drug Quality Assurance | — |
| Oct 2, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 22, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 22, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.