FDA EIR - Shishuka Malhotra MD - August 12, 2010

An FDA inspection of Shishuka Malhotra MD, a clinical investigator in Canton, OH, was conducted from August 5 to August 12, 2010. The inspection, performed under Compliance Program 48.811 for clinical investigators, concluded without significant deviations, and no Inspectional Observations (FDA Form 483) were issued, indicating overall compliance with regulatory requirements for clinical research. Despite the compliant outcome, several informal observations were discussed with Dr. Malhotra and her team. Key points included the practice of archiving source documents for one study with the sponsor off-site, which conflicted with the consent form's assurance that subject records would remain at the site. Dr. Malhotra indicated she would consider maintaining records locally in the future. Other discussions involved two subjects enrolled on disqualifying medications due to differing interpretations of the protocol's drug list, one instance of a missed baseline pregnancy test that was later rectified, and the unauthorized implementation of antidepressant washout periods for several subjects, despite the protocol explicitly prohibiting such a phase. While these items were noted, they did not lead to formal regulatory findings or mandated corrective actions, reaffirming the compliant status of the clinical research site.