FDA 483 - Hetero Labs Limited - Unit III - October 26, 2018

An FDA inspection of Hetero Labs, Ltd. - Unit III in Hyderabad, India, revealed significant deficiencies in their drug manufacturing processes. Observations included a lack of established control procedures to monitor output and validate manufacturing process performance, leading to inconsistent processes and failed batches. Additionally, master production and control records were found to be missing theoretical yield specifications.