FDA EIR - Inotiv Inc - March 08, 2013

An FDA inspection of Bioanalytical Systems Inc. (BASi) in West Lafayette, IN, was conducted from March 4 to March 8, 2013, as a directed analytical bioresearch monitoring activity. This inspection, carried out under compliance program CP7348.001 "In Vivo Bioequivalence," scrutinized data generated for a specific sponsor study involving analytical testing at both their West Lafayette and former UK facilities. The inspection revealed two primary objectionable conditions, resulting in the issuance of an FDA Form 483. The first observation detailed the firm's failure to thoroughly investigate the root cause of observed variations in assay results when utilizing different analytical methods for study samples. This lack of investigation led to the unaddressed application of a correction factor to compensate for the variance in reported data. The second observation pointed to a deficiency in evaluating the full effect on assay results from using distinct diluents for preparing study samples versus those employed for standard calibrators and quality control samples. These issues indicate potential weaknesses in data integrity and method validation processes. Bioanalytical Systems Inc. formally committed to submitting a written response addressing these observations within 15 business days of the inspection's close.