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.
Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination Cohance Lifesciences Limited |
12 Aug 2025 | Normal | Justification: Observations of physical damage (cracks, dents) indicate negligence in Preventive Maintenance. Excerpt: Visible dents on compression machine...large cracks within Tablets/Capsule Counting Machine. View Details |
| Your firm fails to assure that the water system used in production areas provides consistent and uncontaminated water for API synthesis. Not available |
01 Aug 2025 | Normal | Justification: Neglect in maintaining the reverse osmosis system compromises the system's effectiveness and reliability. Excerpt: No preventative maintenance schedule or routine monitoring log available for the reverse osmosis system. View Details |
| Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination Sun Pharmaceutical Industries Ltd. |
13 Jun 2025 | Normal | Justification: The issue stems from failing to maintain equipment, which is directly tied to preventive maintenance neglect. Excerpt: The sealant that covered the cracks at the leaking areas appeared broken and missing sealant. View Details |
| Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination Aurolige Pharma LLC |
10 Apr 2025 | Normal | Justification: The lack of documentation following maintenance directly affects the cleaning process effectiveness, tied to Preventive Maintenance. Excerpt: No cleaning action was recorded in the Log Book following the preventive maintenance. View Details |
| Equipment used in the QC Microbiological Lab is not adequately maintained Genzyme Ireland Limited |
17 Jan 2025 | Normal | Justification: Preventive Maintenance is critical to ensure equipment is kept in a condition suitable for its intended use, as evidenced by the rust observed. Excerpt: Laminar Flow Hood LAF used in in-process control bioburden testing was observed with the HEPA filter screen discolored View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources