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.
Training Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Appropriate controls are not exercised over computers or related systems to assure... Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Employees' inability to perform basic operations indicates insufficient training and knowledge transfer on software use. Excerpt: You have not trained your personnel on their operations (i.e. Empower 3.6.1...) View Details |
| Your firm failed to establish adequate written procedures for production and process controls Biocon Sdn Bhd |
27 Sep 2024 | Normal | Justification: Observation highlights the gap in operator training specifically related to SOP training for end filling operations. Excerpt: Operators are neither trained nor provided instructions in the SOP for filling machine operations. View Details |
| Responsibilities and procedures for quality units are not in writing and/or followed to ensure the API and intermediates manufactured... Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The observation of repeat training requirements for similar issues demonstrates a flaw in the training management system. Excerpt: Activities at the facility are inadequately completed despite training given. Several personnel retrained on the same topic... View Details |
| Written procedures are not followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch. Granules India Limited |
06 Sep 2024 | Normal | Justification: Improper execution of procedures indicates deficiencies in training management and understanding of SOPs. Excerpt: Your operator verbally confirmed that they did not count the tablets nor did they look at both sides. View Details |
| Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination Zydus Lifesciences Limited |
29 Aug 2024 | Normal | Justification: Effective training is fundamental to ensuring that operators adhere to critical aseptic protocols, preventing contamination. Excerpt: operators touched (b)(4) stoppers with the (b)(4) restricted access barrier system View Details |
Prepare Better for FDA Audits with FDA Tracker
Experience the Future
of Pharma Manufacturing.