FDA 483 - Ipca Laboratories Limited

Ipca Laboratories Ltd. in Piparia, Silvassa, India, a drug product manufacturer, was cited for multiple quality control deficiencies during an FDA inspection. Observations included failures to follow chromatography procedures, scientifically unsound microbiological media growth promotion tests, inadequate filter integrity testing, and insufficient checkweigher functionality testing. These issues indicate significant concerns regarding data integrity, quality control, and adherence to established procedures.