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 |
|---|---|---|---|
| Procedures describing the warehousing of APIs, Intermediates and raw materials are not established. Hetero Labs Limited (Warehouse) |
26 Sep 2025 | Normal | Justification: Temperature and humidity are mentioned as unmonitored in the storage description. Excerpt: B) there is no system or mechanism for monitoring warehouse temperature and humidity for APIs. View Details |
| The Quality Unit has not established adequate procedural controls and oversight Dr. Reddy's Laboratories, LTD, Biologics |
12 Sep 2025 | Normal | Justification: Environmental monitoring is directly challenged by the inaccuracies and discrepancies in data management. Excerpt: Environmental monitoring data from data collection sheets are manually entered into uncontrolled electronic spreadsheets. View Details |
| Aseptic processing area are deficient regarding the system for monitoring environmental conditions Aurobindo Pharma Ltd. |
05 Sep 2025 | Normal | Justification: Environmental monitoring directly relates to the observation which highlights deficiencies in monitoring processes. Excerpt: lack of viable EM and non-viable particle count (NVPC) monitoring of the Grade A LAF in Line. View Details |
| Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair. Aurobindo Pharma Ltd. |
05 Sep 2025 | Normal | Justification: Environmental monitoring is impacted as standing water introduces potential contamination risks requiring regular assessments. Excerpt: Puddles of water accumulated and a plastic bag collecting rainwater near entry doorways. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed Right Value Drug Stores LLC |
18 Jul 2025 | Normal | Justification: Environmental monitoring outside critical contact areas fails to assure sterility in aseptic processing. Excerpt: EM sampling was performed outside of the operator's critical contact areas as defined by SOP 4.090. View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources