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.
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US FDA finds flawed data integrity, investigations, aseptic practices and more at range of foreign and domestic drug product manufacturing facilities, while a bankruptcy leads to a massive drug recall.
Warning letters examined in part five of our in-depth report showed how prescription drug firms got into trouble with the US FDA in 2022 by conducting investigations that were too narrow and that failed to trigger appropriate corrective actions. Several firms failed in their sterile injectables contamination investigations. Other inquiries failed to establish proper control of tablet and capsule manufacturing.
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.