483
Haematologic Technologies, LLC dba ProlytixFDA 483 - Haematologic Technologies, LLC dba Prolytix - April 17, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Inspection Date
- April 17, 2026
- Product Type
- Biologics
Open in Dashboard
ID · 80d3a07e-2543-4948-9212-090575f880cd