# FDA 483 - Haematologic Technologies, LLC dba Prolytix - May 11, 2017

Source: https://www.globalkeysolutions.net/records/483/haematologic-technologies-llc-dba-prolytix/aea0025e-2196-4a23-bc0c-9adb9107d7cf

> FDA 483 for Haematologic Technologies, LLC dba Prolytix on May 11, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haematologic Technologies, LLC dba Prolytix
- Inspection Date: 2017-05-11
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Haemtech Biopharma Services, a control testing laboratory in Essex Junction, VT, identified a significant deficiency in their quality control strategies. The firm failed to ensure that all original laboratory records, including electronic data, were subjected to a documented second-person review for accuracy. This observation highlights a concern regarding data integrity and proper reporting of test results for client drug samples.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

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