# FDA 483 - Haematologic Technologies, LLC dba Prolytix - April 17, 2026

Source: https://www.keypedia.com/records/483/haematologic-technologies-llc-dba-prolytix/80d3a07e-2543-4948-9212-090575f880cd

> FDA 483 for Haematologic Technologies, LLC dba Prolytix on April 17, 2026. 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: 2026-04-17
- Product Type: biologics
- Office Name: New England District Office
- Summary: Haematologic Technologies, LLC, a contract testing laboratory in Essex Junction, VT, was cited for failing to thoroughly review out-of-specification (OOS) results before retesting. The firm did not follow its own written procedures for repeat analysis and lacked documentation for root cause investigations of initial OOS results. This led to retesting without proper investigation into batch failures.

## Related Documents

- [483 - 2017-05-11](https://www.keypedia.com/records/483/haematologic-technologies-llc-dba-prolytix/aea0025e-2196-4a23-bc0c-9adb9107d7cf)
- [483 - 2019-06-25](https://www.keypedia.com/records/483/haematologic-technologies-llc-dba-prolytix/db36ede5-1f24-42eb-ad4d-6269ad163601)
- [483 - 2021-07-30](https://www.keypedia.com/records/483/haematologic-technologies-llc-dba-prolytix/a561a2e6-e6dc-4360-a63a-015dd6a9a2ca)

## Related Officers

- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

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

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