FDA 483 - Medilink Hospital and Research Center - January 21, 2020

Medilink Hospital and Research Centre in Ahmedabad, India, a bioequivalence clinical facility, was cited for failing to conduct foreign clinical studies in accordance with good clinical practice during an inspection from January 15-21, 2020. The inspection revealed multiple instances where subjects were not screened or tested as required by study protocols. This indicates significant deviations in the execution of clinical trials.