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

Published On 18 Feb 2021 05:28 PM


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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....


Tags : Alembic Pharma, US FDA, Karkhadi, ,
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