FDA EIR - Shishuka Malhotra MD - October 14, 2010

An FDA inspection of Shishuka Malhotra MD (Neuro-Behavioral Clinical Research) in Canton, OH, was conducted from October 4-14, 2010. The inspection, performed under regulatory guidelines for clinical investigators (CP 7348.811 and referencing 21 CFR 312.60), identified significant non-compliance issues, documented in an FDA Form 483.

Main violations included enrolling a subject who met the post-herpetic neuralgia pain duration requirement for approximately five months instead of the mandated six. Two other subjects were randomized despite not taking concomitant NSAID medications at a stable dose for the required 30 days prior to screening. Furthermore, one subject was prematurely dispensed and took tapering study medications during the second week of the trial, leading to improper titration and early discontinuation.

Dr. Malhotra acknowledged the FDA 483 observations. She outlined corrective practices implemented to prevent recurrence, such as developing study-specific pre-screening and eligibility worksheets, tracking medication start/stop dates, utilizing a consent form revision flow sheet, and providing written instructions to subjects regarding study medication use.