# FDA 483 - NORTHEAST BIOLAB - December 05, 2025

Source: https://www.globalkeysolutions.net/records/483/northeast-biolab/f549d6b8-52ef-4bd9-b587-11636694953a

> 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: New England District Office
- Summary: 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.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144