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Tyche Industries Ltd, an active pharmaceutical ingredient manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered its APIs adulterated. FDA inspectors documented serious data integrity failures, including operators falsifying temperature records for a drying oven during batch manufacture and quality assurance staff backdating calculation sheets provided to investigators. The company's response was deemed inadequate, proposing a ten-month timeline to address critical data integrity gaps despite the severity of the documented misconduct.