# FDA 483 - NORTHEAST BIOLAB - December 05, 2025

Source: https://www.keypedia.com/records/483/northeast-biolab/b0049592-23a3-4bd8-8d13-4467eabaeeee

> FDA 483 for NORTHEAST BIOLAB on December 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NORTHEAST BIOLAB
- Inspection Date: 2025-12-05
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: 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.

## Related Documents

- [483 - 2025-12-05](https://www.keypedia.com/records/483/northeast-biolab/f549d6b8-52ef-4bd9-b587-11636694953a)

## Related Officers

- [Melkamu Getie Kebtie](https://www.keypedia.com/people/melkamu-getie-kebtie/e7c26e5f-2f7f-46ad-83bc-09006f3cdc26)

Company: https://www.keypedia.com/companies/northeast-biolab/df8bbc09-ec35-4998-88e5-8b66c2764e36

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917