Haematologic Technologies, LLC dba ProlytixJuly 30, 2021

FDA 483 - Haematologic Technologies, LLC dba Prolytix - July 30, 2021

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Record Details

Haematologic Technologies, LLC, a contract testing laboratory in Essex Junction, VT, was cited for two observations during an FDA inspection. The firm failed to consistently follow its written procedures, specifically regarding Quality Assurance consultation during assay performance and the correct number of injections for a test method. Additionally, the firm did not adequately qualify test reagents for their intended purpose, leading to an invalid assay due to lot-to-lot variability.

Company: Haematologic Technologies, LLC dba Prolytix
Inspection Date: July 30, 2021
Product Type: Biologics
Office: Division of Northeast Imports
Person: Steven E. Bowen (Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics)

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ID · a561a2e6-e6dc-4360-a63a-015dd6a9a2ca