FDA 483 - NORTHEAST BIOLAB - December 05, 2025

An FDA inspection of NorthEast BioLab, a bioanalytical analytical facility in Hamden, CT, revealed a significant issue with method validation reporting. The firm failed to include all tested analytical batches in the run summary table of a method validation report, specifically omitting several batches related to standard stock comparison, precision & accuracy, and various stability tests. This indicates a concern with data integrity and complete documentation of analytical procedures.