# FDA 483 - Haematologic Technologies, LLC dba Prolytix - June 25, 2019

Source: https://www.globalkeysolutions.net/records/483/haematologic-technologies-llc-dba-prolytix/db36ede5-1f24-42eb-ad4d-6269ad163601

> FDA 483 for Haematologic Technologies, LLC dba Prolytix on June 25, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haematologic Technologies, LLC dba Prolytix
- Inspection Date: 2019-06-25
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Haematologic Technologies Inc., a contract testing laboratory in Essex Junction, VT, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate or absent written procedures, failure to investigate out-of-specification results, lack of electronic data management protocols, and insufficient quality oversight for contract services. These issues indicate significant gaps in the firm's quality system and data integrity practices.

## Related Documents

- [483 - 2017-05-11](https://www.globalkeysolutions.net/records/483/haematologic-technologies-llc-dba-prolytix/aea0025e-2196-4a23-bc0c-9adb9107d7cf)
- [483 - 2021-07-30](https://www.globalkeysolutions.net/records/483/haematologic-technologies-llc-dba-prolytix/a561a2e6-e6dc-4360-a63a-015dd6a9a2ca)

## Related Officers

- [Jason D Abel](https://www.globalkeysolutions.net/people/jason-d-abel/42c4bafe-17bb-4a43-80cd-83dd77b3426d)
- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)

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