FDA EIR - Keystone Bioanalytical, Inc. - June 28, 2019

An FDA surveillance inspection of Keystone Bioanalytical, Inc., a contract research organization in North Wales, PA, took place from June 24-28, 2019. Conducted under the "Procedures for FDA Staff: In Vivo Bioavailability/Bioequivalence Studies (Analytical)" compliance program, this inspection reviewed bioanalytical data for four studies and their associated method validations. The inspection resulted in one observation on Form FDA 483 and one verbal observation. The primary violation cited was the firm's failure to report all method validation data for method validation (b) (4). Specifically, results from certain samples in Run V06 were excluded from precision and accuracy statistical analysis. When these results were included, the inter-batch precision was found to be out-of-specification (CV > 15%) at a particular concentration, violating 21 CFR 320.29(a). The verbal observation noted insufficient documentation regarding the use of a specific working solution for preparing a calibration standard in multiple runs of method validation (b) (4). Management acknowledged both observations, committing to a written response with proposed corrective actions within 15 business days for the FDA 483, and pledged to ensure complete and accurate documentation in future operations.