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.
Laboratory Controls
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| You have not established Laboratory controls that include the establishment of scientifically sound and appropriate specifications Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Observation highlights failure in laboratory controls, evident from lack of stability testing and revalidation omissions. Excerpt: An on-going testing program to monitor the stability characteristics of APIs is not established and followed. View Details |
| Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements OSRX Inc. |
25 Oct 2024 | Normal | Justification: Sterility testing, a critical laboratory control, was not verified before product release, compromising quality. Excerpt: sterility testing being completed by your third party laboratory as documented... View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: Laboratory controls play a crucial role in ensuring product conformity to quality standards. This observation highlights discrepancies in this area. Excerpt: Your firm failed to provide scientific rationale to support established limits for subvisible particles in Avastin. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures Empower Pharmacy |
28 Aug 2024 | Normal | Justification: The issue stems from inadequate laboratory controls which are fundamental for proper testing and documentation, as highlighted in the observation. Excerpt: Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Belcher Pharmaceuticals, LLC |
16 Aug 2024 | Normal | Justification: Observations point to deficiencies in laboratory control procedures leading to oversight in impurity testing. Excerpt: Your firm failed to conduct testing for impurities as part of your finished product specification requirements prior to batch release. View Details |
Prepare Better for FDA Audits with FDA Tracker
Experience the Future
of Pharma Manufacturing.