FDA WARNING_LETTER - Shah, Ashok M.D. - May 17, 2007

An FDA inspection conducted between April 30 and May 17, 2007, by Ms. Brunilda Torres, reviewed Dr. Ashok Shah's conduct of clinical investigations for Telithromycin (Ketek?) for Sanofi-Aventis Pharmaceuticals (Protocols [redacted] and [redacted]). The inspection, part of the Bioresearch Monitoring Program, found that Dr. Shah failed to adhere to statutory requirements and FDA regulations for clinical investigations and human subject protection. Key violations included: 1) Failure to conduct studies according to the investigational plan (21 CFR 312.60), involving issues like enrolling ineligible subjects, not performing required pregnancy tests, enrolling subjects with exclusion criteria, allowing prohibited concomitant medications, improper study drug storage, and failing to document concomitant medications and adverse events. 2) Failure to maintain adequate and accurate case histories (21 CFR 312.62(b)), evidenced by undated retroactive annotations, unexplained data corrections, and discrepancies across source documents. 3) Failure to obtain informed consent prior to subject involvement (21 CFR 50.20). 4) Failure to properly document written informed consent, with subjects not signing or dating the documents (21 CFR 50.27(a)). 5) Failure to provide subjects with a copy of the signed and dated informed consent document (21 CFR 50.27(a)). These deficiencies raise serious concerns about data validity and subject safety. Dr. Shah must respond within fifteen working days, detailing corrective actions to prevent future violations, or face potential regulatory action.