A manufacturing plant operated by Spanish API maker Medichem has passed an inspection by the US FDA for the fifth time in a row.
The facility in Girona was visited by the Food and Drug Administration (FDA) earlier this month. The agency looked at both general active pharmaceutical ingredients (APIs) made at the site as well as several ingredients for which Medichem had been pre-approved.
Medichem did not revive any 483, which is a result matched by its facility in Malta when it was inspected by the FDA earlier this year.
Ervin Veszprémi, Medichem’s CEO, commented: “We are very happy with the outcomes of this year’s FDA inspections. Two inspections without “Form 483” in a single year and 13 years without a single observation underline what we are all about: Unique products for the generics industry at the highest level of quality”.