FDA inspection in Hal Far (Malta) with no “Form 483” for the second consecutive time

Medichem Malta plant passed a US FDA inspection for the second consecutive time without receiving any observation.

The inspection of Medichem’s plant in Hal Far (Malta) was carried out by two FDA officers from the 16th to the 19th of February 2015 and covered Good Manufacturing Practice (GMP) systems, as well as several Active Pharmaceutical Ingredients (APIs) exported to the US.