ALEMBIC PHARMA UNIT UNDER THE SCANNER OF US FDA FOR QUALITY CONTROL & EQUIPMENT ISSUES

Highlights

• The US FDA had recently issued a ‘Form 483’ to the Karkhadi unit of Alembic Pharma with five observations

• The FDA issues a ‘Form 483’ in which its inspectors enlist violations of good manufacturing practices by them at the time of their inspection of a facility

• FDA said that the facility failed to provide scientific justification demonstrating that samples co....