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 |
|---|---|---|---|
| OBJECTIVE 1b: A sound and appropriate program for sampling, testing, and evaluating components Not available |
29 Jun 2026 | Normal | Justification: The issue relates directly to the need for robust sampling methods and procedures to effectively evaluate material quality. Excerpt: Check the sampling plans to confirm that representative samples are collected and tested/examined to verify product quality. View Details |
| Other Comments - During our review, we noted multiple prescriptions filled April 14, 2025, to June 30, 2025, from the same prescriber at a county humane society for two different animals Mixlab WI LLC |
01 May 2026 | Normal | Justification: The observation indicates an issue related to mismanagement or misuse of prescribed medicinal samples, which falls under improper Sample Management practices. Excerpt: lack of patient-specific dosing instructions despite specific owner names being listed for both patients View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: Sample Management is directly impacted due to improper collection and handling, leading to false data entries. Excerpt: Microbiologists potentially falsified sample collection data and skipped primary gowning. View Details |
| Established sampling plan and test procedures are not followed Global Calcium Pvt. Limited |
03 Feb 2026 | Normal | Justification: Sample management is linked as deficiencies were observed in documented sampling activities versus biometric access logs. Excerpt: Water Sampling Register does not match biometric access logs, indicating procedural breakdown in sample management. View Details |
| Established sampling plan and test procedures are not followed Gland Chemicals Private Limited |
27 Nov 2025 | Normal | Justification: Sample Management is impacted as discrepancies in presence documentation risk sample integrity and trustworthiness of data. Excerpt: The biometric access control system does not show that employee entered the room during the sampling period. View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources