FDA 483 - Dr. A. Sharda - April 07, 2016

The FDA conducted an inspection of A. Sharda, M.D., a clinical investigator in Bangalore, India, from March 28 to April 7, 2016. The inspection revealed significant deviations from Good Clinical Practice (GCP) requirements during a clinical study. Primary violations centered on inadequate and inaccurate record-keeping, including missing source documents for local laboratory values, inconsistent lab reports, and disposed blood/urine logs. There were numerous instances of inaccurate data reporting in electronic case report forms (eCRFs), such as secondary efficacy endpoints, hypoglycemia episodes, and undocumented or unexplained changes in medication doses and medical events, lacking proper dating and initials.

Furthermore, the investigation deviated from the approved study plan. Issues included the inconsistent use of various laboratories for critical tests like HbA1c without proper contracts, and the enrollment of subjects who did not meet specific inclusion criteria, particularly regarding medication status and duration of therapy. Required annual laboratory tests were also omitted for some subjects. A conflict of interest was identified within the Ethics Committee, with a member conducting the same study at another site. Finally, the disposition of returned investigational product was not adequately documented. To address these serious deficiencies, A. Sharda, M.D. is required to implement comprehensive corrective actions to ensure compliance with regulatory standards for clinical investigations, upholding data integrity and patient safety.