FDA 483 - Labcorp Early Development Laboratories, Inc. - April 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.
An FDA inspection of Labcorp Early Development Laboratories, Inc. in Greenfield, IN, a nonclinical laboratory, revealed significant deficiencies in Good Laboratory Practices. Observations included failures in accurately recording experimental data, inadequate equipment inspection and maintenance, and a lack of established standard operating procedures for handling test and control articles. These issues indicate potential systemic problems in ensuring data integrity and operational quality.
ID · a0c6dcc4-13b3-491f-b63f-857cdcb5a19e