FDA 483 - Intas Pharmaceuticals Ltd. - January 20, 2023
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An FDA inspection of Intas Pharmaceuticals Ltd. in Dehradun, India, a finished drug product manufacturer, revealed significant deficiencies across multiple areas. The firm failed to establish and follow procedures for preventing microbiological contamination in sterile and non-sterile drug products, and lacked scientific evidence in out-of-specification investigations. Critical issues were also noted in process validation, equipment qualification, quality control unit oversight, and data integrity for computerized systems.
ID · 21016793-b807-41b4-97f1-d21510336034