FDA 483 - Lupin Limited - July 17, 2015

This FDA Form 483 details observations from an inspection, primarily focusing on deficiencies in the Laboratory Control System, Quality System, and Materials System.

**Laboratory Control System:** * **Observation 1:** Drug products failing specifications are not rejected. Specifically, multiple batches with Out-of-Specification (OOS) in-process results were released and distributed without invalidating the OOS results. One finished product batch was rejected due to not meeting specifications, but the rejection disposition did not link it to the in-process specification failure. * **Observation 2:** Reserve samples are not visually examined annually for deterioration, contrary to SOP SAP-099-01.

**Quality System:** * **Observation 3:** Unexplained discrepancies and batch failures are not thoroughly reviewed. Over 40 complaints regarding product suspension since launch lacked thorough investigations, failing to include multi-attribute assessments, evaluation of diluent leaks (shipping vs. packaging), thorough evaluation of root causes (e.g., patient non-compliance), and investigational testing to support hypotheses. * **Observation 4:** SCADA system inputs/outputs for in-process checks are not checked for accuracy at a suitable frequency. * **Observation 5:** Defined processing areas (compression, capsule filling) and control systems (cleaning with non-dedicated mops, mop replacement frequency, cleaning frequency of areas/corridors) are deficient. Cleaning schedules and the use of