Intercept Pharmaceuticals – FDA EIR, Feb 1, 2016

An FDA inspection of Intercept Pharmaceuticals, Inc. in San Diego, CA, occurred from January 19 to February 1, 2016. This initial inspection focused on clinical trial protocols for NDA 207999 (Obeticholic Acid) and identified three significant deficiencies, leading to the issuance of an FDA-483 form. The main violations included the company's failure to adequately review and approve clinical trial monitoring reports in a timely manner, with some approvals delayed by up to 595 days, and inadequate written procedures for this process. Secondly, the company failed to ensure proper record retention; original paper documents were destroyed after scanning without evidence that the electronic copies were certified for authenticity, integrity, and accuracy. Lastly, Intercept Pharmaceuticals, Inc. lacked a written master laboratory service agreement to formally transfer specific testing responsibilities to a contract research organization for one of its study protocols. These issues relate to regulatory frameworks governing sponsor responsibilities and recordkeeping for investigational new drug applications. Dr. Linda M. Robertson, V.P. Regulatory Affairs and Quality Assurance, accepted the observations and committed to providing a written response to the FDA within 15 calendar days. Further discussions involved discrepancies in laboratory data and missing documentation, which the company pledged to investigate and address with the Agency.