Experience Leucine AI.
Powered Pharma Operations

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.

Optimize your manufacturing processes with paperless operations
Strengthen quality management and regulatory compliance
Accelerate laboratory operations and testing workflows

Connect with a Leucine Expert

Schedule a 30-Minute Product Demo with Expert Q&A

Sub System
Waste Management

Waste Management

View Detailed Analysis

Analytics Overview

1
Form 483s Issued
0
483s converted to WL
1
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
16 Jan 2024
Jiangsu Hengrui Pharmaceuticals Co., Ltd
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
1
0
Qiao Y Bobo
1
0
TITLE/ COMPANY Issue Date Status Details
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality, and purity of drug products
Jiangsu Hengrui Pharmaceuticals Co., Ltd
16 Jan 2024 Normal Justification: The observation relates to the improper handling and security of drug products awaiting destruction, linking to Waste Management.
Excerpt: Parenteral drug products awaiting destruction in your waste area are not secure. During our (b) (4) walkthrough on 01/08/2024 we observed doors to your waste building open and no personnel present.
View Details

Prepare Better for FDA Audits with FDA Tracker

Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
Stay Compliant: Manage risks proactively.