FDA 483 - Lupin Limited - October 18, 2018

An FDA inspection of Lupin Limited in Pithampur, India, revealed significant deficiencies across its drug manufacturing operations. Observations included inadequate process performance qualification, deficient cleaning validation for multi-use rooms and equipment, and poor controls over computerized systems in the QC laboratory. Additionally, the firm's sampling procedures for APIs and acceptance procedures for incoming devices were found to be inadequate.