FDA EIR - AB Science - September 26, 2014

An FDA inspection of AB Science, Paris, France, was conducted from September 22-26, 2014, as a for-cause follow-up under CDER Compliance Program 7348.810. The inspection, with participation from the French regulatory authority (ANSM), revealed significant deficiencies in the company's oversight and monitoring of clinical investigations, particularly concerning its investigational drug, (b)(4). Key violations included the failure to properly monitor clinical investigations, provide investigators with necessary information, and ensure studies adhered to general plans and protocols. Monitors consistently failed to deliver adequate investigator training, submit timely reports, and retrieve local clinical laboratory results. Several principal investigators were absent during critical site initiation and interim monitoring visits, and AB Science lacked clear procedures for addressing investigator non-compliance. A notable lapse involved an investigator's failure to modify a subject's drug dose despite Grade 2 renal failure, violating protocol stopping rules, which the sponsor did not address. The FDA issued a Form 483 to CEO Mr. Alain Moussy, who committed to implementing corrective actions. These included plans to enhance monitoring programs, establish a robust Quality Assurance System, set stringent reporting timelines for Clinical Research Associates, and allocate increased resources for quality control, potentially engaging external auditors. This inspection built upon previous findings of recordkeeping deficiencies, inaccurate reporting, and inadequate safety information disclosures.