483
Eurofins EAG Materials Science LLCFDA 483 - Eurofins EAG Materials Science LLC - December 11, 2025
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
Eurofins EAG Materials Science LLC in Maryland Heights, MO, was inspected from December 8-11, 2025, and received a Form 483. The inspection revealed a significant issue with computer system controls, specifically the ability for users to alter time in cGMP systems and the lack of time zone information in audit trails, indicating potential data integrity concerns. This observation is similar to a previous finding from 2019.
Open in Dashboard
ID · f36ecc7e-18dc-44a0-ac0b-0438366171b5