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.
Cleaning Validation
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Cleaning validation is directly linked as there's a failure to conduct necessary validations for equipment cleaning. Excerpt: You established a campaign cleaning frequency...without performing any cleaning validation... View Details |
| Your firm failed to appropriately clean equipment located in the ISO 5 area. Brookfield Medical Surgical Supply, Inc. |
27 Sep 2024 | Normal | Justification: Cleaning Validation is directly compromised due to failure to execute required cleaning protocol after a contamination event. Excerpt: Your firm failed to perform a (b) (4) clean after ... an objectionable organism identified. View Details |
| Written procedures are not established for cleaning of equipment and its subsequent release for use Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: Cleaning Validation is directly connected as the primary issue is with validation of cleaning methods and evidence. Excerpt: Your firm has not established adequate cleaning validation for your equipment located in Plant and (b) Plant (4) used in the production of the APIs for the U.S. market. View Details |
| Building and facilities are not maintained to ensure that products manufactured meet the quality Granules India Limited |
06 Sep 2024 | Normal | Justification: Observation highlights visible contamination and microbial growth which suggests failures in cleaning validation. Excerpt: Swab analyses test results revealed presence of drug substances... and colonies of bacterial and yeast. View Details |
| Building and facilities are not maintained to ensure that products manufactured meet the quality, purity characteristics Granules India Limited |
06 Sep 2024 | Normal | Justification: Cleaning validation ensures the removal of potential contaminants, critical for product safety. Excerpt: APUs, AHUs, and equipment covered with apparent off-white to white powdery materials and dust. View Details |
Prepare Better for FDA Audits with FDA Tracker
Experience the Future
of Pharma Manufacturing.