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.
Field Alert Report
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product Sun Pharmaceutical Industries Limited |
15 Dec 2023 | Normal | Justification: The issue specifically relates to the failure to submit necessary Field Alert Reports as mandated by both FDA regulations and internal SOPs, evidencing a direct linkage to the Field Alert Report process type. Excerpt: "An (b) (4) -Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product." View Details |
| failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications Dr. Reddy's Laboratories Ltd. |
27 Oct 2023 | Normal | Justification: The delay in filing the Field Alert Reports and improper closure without proper evaluation highlights a critical gap in the Field Alert Report handling process. Excerpt: The firm initiated a separate OOS investigation and filed a Field Alert on 25-Jan-2021 to the agency. View Details |
| Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required Samsung Bioepis Co., Ltd. |
15 Sep 2023 | Normal | Justification: The observation pertains to the delay in submission of post marketing 15-day alert reports, directly tying it to the Field Alert Report process type. Excerpt: Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required. View Details |
| An Field Alert Report was not submitted within of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application. Cipla Limited |
17 Feb 2023 | Normal | Justification: The observation explicitly mentions the failure to submit the Field Alert Report as per SOP 1035-G-0014, highlighting a direct issue with the Field Alert Report process. Excerpt: Quality Unit failed to submit a Field Alert Report (FAR) as required under SOP (b) (4) (1035-G-0014, Version: 7.0), "Field Alert Report" for complaints received. View Details |
Prepare Better for FDA Audits with FDA Tracker
Experience the Future
of Pharma Manufacturing.