483
St. Theresa's General HospitalFDA 483 - St. Theresa's General Hospital - June 08, 2012
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An FDA inspection of St. Theresa's General Hospital, a clinical facility in Hyderabad, India, identified significant deviations from study protocols during a bioequivalence study. Observations included failures to adhere to subject inclusion/exclusion criteria and improper blood sampling procedures. These findings indicate a lack of adherence to established research protocols.
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ID · a84f3703-2efc-4165-9af2-4eb89fe1a28f