FDA 483 - Sentiss Pharma Pvt. Ltd. - May 23, 2017

Geniss Pharma Pvt. Ltd., a sterile drug manufacturer in District Solan, India, was inspected by the FDA, revealing significant deficiencies. The inspection highlighted inadequate investigations into discrepancies and data integrity issues, failures in aseptic processing procedures, and a lack of proper quality control and change control. Laboratory controls were also found to be deficient, with issues in specifications, testing, and record-keeping.