Drug factory · FDA FEI 3011691465
Porton Biopharma Limited
Salisbury, United Kingdom
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, May 21, 2021.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
3 drug inspections on record since 2016: 0 with no problems, 0 with problems fixed voluntarily, 3 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Asparaginase | Makes it | Porton Biopharma Limited | 81561-413 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 21, 2021 | Serious problems, FDA action | Drug Quality Assurance | — |
| Aug 1, 2018 | Serious problems, FDA action | Drug Quality Assurance | — |
| Mar 18, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |