FDA EIR - IAL Biolytix - July 23, 2004

An FDA inspection of IAL Biolytix, a bioanalytical contract laboratory in Monmouth Junction, NJ, was conducted from July 20-23, 2004. This initial inspection focused on the analytical components of a New Drug Application (NDA (b) (4)) under the regulatory framework of "In Vivo Bioequivalence." The inspection identified three significant observations, leading to the issuance of an FDA-483. Firstly, the company failed to reject data from an analytical run where a high percentage of low Quality Control (LQC) samples did not meet acceptance criteria. Secondly, the analytical method demonstrated insufficient sensitivity at the Lower Limit of Quantitation (LLOQ) and for LQC samples, exhibiting high imprecision (26% at LLOQ, and 53% and 17.5% for LQC samples). Furthermore, the firm did not investigate the source of significant interference observed in numerous samples. Lastly, IAL Biolytix lacked a monitoring system for its bioequivalence sample storage equipment during non-operational hours, risking abnormal storage conditions. In response, company management committed to submitting a written plan detailing corrective actions to address these findings.