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 |
|---|---|---|---|
| Failure to maintain equipment and facilities in a good state of repair Hospira, Inc. |
10 Mar 2026 | Normal | Justification: The observation directly highlights deterioration and wear, which indicates failures in preventive maintenance practices ensuring equipment functionality. Excerpt: The(b) (4) used in drug product manufacture was observed with deteriorated sealant and extensive (b) (4) scoring. View Details |
| Failure of the Quality Unit to fulfill its oversight responsibilities Aurorium LLC |
06 Mar 2026 | Normal | Justification: Preventive maintenance linkage due to absence of SOPs governing work order creation for equipment maintenance. Excerpt: Your firm has no written SOP governing the circumstances that would warrant the creation of a work order. View Details |
| Failure to properly maintain buildings, facilities and equipment used in the manufacture of active pharmaceutical ingredients Aurorium LLC |
06 Mar 2026 | Normal | Justification: Preventive maintenance lapses allowed facility and equipment degradation to remain unaddressed, creating compliance risks. Excerpt: Water leaking from equipment...corrosion...deterioration. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. Maiva Pharma Private Limited |
20 Feb 2026 | Normal | Justification: Preventive Maintenance is involved as it directly pertains to the maintenance of AHUs which affects pressure differentials. Excerpt: Your firm has not established and followed adequate written procedures to ensure maintenance of appropriate pressure differentials and airflow patterns during shutdown ... View Details |
| Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product. Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: The lack of preventive maintenance attention directly connects to the Preventive Maintenance process type issues. Excerpt: SOP No.: FU7-EN-MNP-007... has no mention of Quality Unit responsibilities... View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources