Four Indian Pharma sites issued Warning letters in July 2023 – Intas , Centaur, Medgel, Baxter

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Warning letter Intas

Warning letter Centaur

Warning letter Medgel

Warning letter Baxter

Intas Warning letter cites serious Data integrity issues, deficient Laboratory controls, Document controls and Quality and Management oversight, Baxter is cited for deficiencies in Cleaning and Maintenance of equipment, Particulate matter, Visual inspection and investigations into Endotoxin failures.  Medgel Warning letter cites Invalidation of OOS without justification, inadequate Investigations of deviations, inadequate oversight of Quality unit and failure to ensure Data Integrity, deficiencies in Component testing of Propylene glycol, Glycerin and Sorbitol for Diethylene glycol (DEG) and Ethylene Glycol (EG) contaminants. Warning letter for Centaur cites deficiencies in Equipment cleaning and cleaning verification, Quality unit oversight and failure to implement Quality function and Inadequate failure investigations.