FDA 483 - Hetero Labs Limited - Unit III - March 23, 2018

Hetero Labs, Ltd. - Unit III, a drug manufacturer in Hyderabad, India, was cited for significant deficiencies in its manufacturing and laboratory controls. Observations included incomplete master production records lacking detailed sampling procedures, failure to adhere to the stability testing program's timelines, and inadequate laboratory records missing documentation of reference standards, equipment, and reagents. These issues indicate a lack of robust quality control and record-keeping practices.