Drug factory · FDA FEI 3002807299
Interpharma Praha, a.s.
Prague 12, Czech Republic
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Serious problems, FDA action at FDA's last inspection, Oct 16, 2015.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
2 drug inspections on record since 2012: 1 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Iohexol | Makes it, makes the active ingredient and tests it | Interpharma Praha, a.s. | 54702-501 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 16, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| Aug 23, 2012 | No problems found | Drug Quality Assurance | — |