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 designed to prevent microbiological contamination of drug products purporting to be sterile Eugia Pharma Specialities Limited |
06 Feb 2026 | Normal | Justification: Process validation is pivotal in ensuring aseptic processes meet predefined standards during production. Excerpt: do not demonstrate there is appropriate air laminarity during commercial operation. View Details |
| Procedures designed to prevent microbiological contamination of drug products JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy |
19 Dec 2025 | Normal | Justification: The observation highlights a failure in simulating actual production conditions, indicating a process validation issue. Excerpt: Media fills or aseptic process simulations performed do not closely simulate actual production conditions or cover worst case conditions. View Details |
| The final and intermediate containers/closures used for drug product intended to be sterile have not been sterilized or depyrogenated. JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy |
19 Dec 2025 | Normal | Justification: Process validation is critical to ensuring each sterilization cycle meets quality standards and regulatory compliance. Excerpt: Your firm has not validated the re-sterilization process and has no procedure or process for tracking the number of sterilization cycles for (b) (4) stoppers. View Details |
| Control procedures are not established which validate the performance of those manufacturing processes Dr. Reddy's Laboratories Limited |
12 Dec 2025 | Normal | Justification: Process Validation is required to confirm that manufacturing changes do not affect product quality. Excerpt: Control procedures are not established which validate the performance of those manufacturing processes. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation Shilpa Medicare Limited |
21 Nov 2025 | Normal | Justification: Process validation linked to observation through inadequate aseptic process and requalification procedures. Excerpt: Your firm's written procedure for requalification does not include sufficient detail for consistent replication of worst-case challenge conditions. View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources