NORTHEAST BIOLABDecember 5, 2025

FDA 483 - NORTHEAST BIOLAB - December 05, 2025

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An FDA inspection of NorthEast BioLab in Hamden, CT, a bioanalytical analytical facility, identified a significant issue with method validation reporting. The firm failed to include all tested analytical batches in the run summary table for method validation MET358 v1 and its addendum 1, indicating potential data integrity or documentation deficiencies. This suggests a need for improved quality control and reporting practices.

Company: NORTHEAST BIOLAB
Inspection Date: December 5, 2025
Product Type: Drugs
Office: Division of Blood Components and Devices
Person: Melkamu Getie-Kebtie

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ID · b0049592-23a3-4bd8-8d13-4467eabaeeee