FDA EIR - Sarah E. Zauber, M.D. - September 16, 2021

An FDA inspection of Sarah E. Zauber, M.D., located in Indianapolis, IN, was conducted from September 13 to September 16, 2021. This high-priority, for-cause inspection focused on clinical investigator compliance under the FD&C Act and Compliance Program 7348.811, specifically regarding pre-market Investigational New Drug studies.

The primary violation noted on the FDA Form 483 (Inspectional Observations) related to a failure to conduct an investigation in accordance with the investigational plan, as required by 21 CFR 312.60. Specifically, for one clinical study, the Institutional Review Board (IRB) had mandated reconsenting subjects with revised consent forms that included newly identified risks. However, four enrolled subjects were either not reconsented as instructed or were initially consented using outdated versions of the form, depriving them of timely, critical risk information. Subjects were reconsented several months later, after their initial enrollment.

Additionally, a minor Good Clinical Practices issue was discussed regarding improper corrections (write-overs) on study records, with a reminder provided on appropriate documentation practices (single line-through, initial, and date).

Management acknowledged the consent issue, stating it had been reported to the IRB and new internal procedures were in place to prevent recurrence. They committed to providing a formal written response within fifteen business days and retraining staff on documentation standards.