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

Source: https://www.globalkeysolutions.net/records/483/haematologic-technologies-llc-dba-prolytix/a561a2e6-e6dc-4360-a63a-015dd6a9a2ca

> FDA 483 for Haematologic Technologies, LLC dba Prolytix on July 30, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haematologic Technologies, LLC dba Prolytix
- Inspection Date: 2021-07-30
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: 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.

## Related Documents

- [483 - 2017-05-11](https://www.globalkeysolutions.net/records/483/haematologic-technologies-llc-dba-prolytix/aea0025e-2196-4a23-bc0c-9adb9107d7cf)
- [483 - 2019-06-25](https://www.globalkeysolutions.net/records/483/haematologic-technologies-llc-dba-prolytix/db36ede5-1f24-42eb-ad4d-6269ad163601)

## Related Officers

- [Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics](https://www.globalkeysolutions.net/people/steven-e-bowen/0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c)

Company: https://www.globalkeysolutions.net/companies/haematologic-technologies-llc-dba-prolytix/03297ca5-f207-401a-8202-1b343903beed

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7