FDA 483 - Laboratorios Rety de Colombia S A S - December 06, 2019

An FDA inspection of Laboratorios Rety de Colombia S A S in Barranquilla, Colombia, revealed two significant observations. The firm failed to perform assay testing for finished drug products prior to release, relying instead on bulk product testing without scientific justification. Additionally, control procedures for manufacturing processes were found to be inadequate, specifically regarding the validation of critical process parameters.