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US FDA releases details of observations on Alkem's Baddi Plant

The US FDA had conducted an inspection of the facility last month and had made ten procedural observations, including issues with cleanliness and the company's failure to keep written documents on quality control procedures.

United-states , Alkem-laboratorie-baddi , Drug-administration , United-states-food , Good-manufacturing-practices , India , S-fda , Alkem ,