FDA Warns Lupin To Stop Blaming Lab And Fix Manufacturing Processes
Executive Summary
Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.
You may also be interested in...
The Quality Lowdown: Key Inspection Findings At Glenmark, Centrient, Lupin, Aurobindo, Mac-Chem
US and EU drug GMP inspections at API and drug product manufacturing sites in India found fault with investigations, process validation, data integrity and contamination prevention.
Boon For Lupin As FDA Upgrades Somerset Site Status
Looking to provide evidence of its extended measures to improve quality, compliance and oversight, Lupin has received positive news from the FDA for its US-based manufacturing facility in Somerset, New Jersey.
Lupin Appoints New Compliance Manager As More Deficiencies Found
Lupin has named a new head of compliance, emphasizing the importance of achieving the highest quality standards just weeks after the FDA notified the firm of observations following an inspection at its Indian facility in Tarapur.