Powered Pharma Operations
Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.
See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.
Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.
Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.
Investigations
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Investigations into product complaints are inadequate to ensure complaint investigations identify appropriate root causes, assess potential product impact, and implement scientific sound sustainable corrective action and preventive action. Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: The observation indicates deficiencies in the investigation process itself, particularly regarding method alignment and thorough analysis. Excerpt: You conducted an analysis of your reserve sample after receiving the complaint using the same test method initially used for release testing which also failed for PSD analysis. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components OSRX Inc. |
25 Oct 2024 | Normal | Justification: The observation indicates insufficient investigation into failures, impacting product release decisions. Excerpt: Your firm failed to investigate visual inspection failures that exceeded the specification limits without adequate documentation. View Details |
| The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, and packing. Biocon Sdn Bhd |
27 Sep 2024 | Normal | Justification: Investigations are affected due to inadequate linkages between process operations and contamination results. Excerpt: No system to link finger dab results to specific operations during set-up activities makes investigation data unavailable. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch Nephron Sterile Compounding Center LLC |
25 Sep 2024 | Normal | Justification: Failure to conduct complete investigations into returned batches and impurities led to unresolved product quality issues. Excerpt: The other 30 returned vials were not tested for impurities; sterility test did not include growth media. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. Granules India Limited |
06 Sep 2024 | Normal | Justification: The observation indicates that OOS and OOT investigations were not adequately performed, directly relating to the investigation process. Excerpt: Specifically, your investigations pertaining to Out of Specification (OOS) and Out of Trend (OOT) investigations are not thoroughly investigated. View Details |
Prepare Better for FDA Audits with FDA Tracker
Experience the Future
of Pharma Manufacturing.