FDA 483 - Natco Pharma Limited - February 03, 2023

An FDA inspection of NATCO Pharma Limited in Visakhapatnam, India, revealed two significant observations. The firm failed to document production and process control procedures at the time of performance, specifically regarding equipment cleaning logbooks. Additionally, investigations into unexplained discrepancies did not extend to other batches of the same drug product, particularly concerning retroactive assessment of impurity testing methods.