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483
•Labcorp Early Development Laboratories, Inc.•April 11, 2025

Labcorp Early Development Laboratories, Inc. – FDA 483, Apr 11, 2025

Record Details

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.

Company
Labcorp Early Development Laboratories, Inc.
Inspection date
April 11, 2025
Product type
other
Office
Detroit District Office
People
  • Corrine M. Carter (investigator)
  • Chelsea W. Lamm (investigator)
View Company Profile

ID · a0c6dcc4-13b3-491f-b63f-857cdcb5a19e

Other documents for Labcorp Early Development Laboratories, Inc.
  • 483 - 2025-07-25July 25, 2025
  • 483 - 2024-07-12July 12, 2024
  • 483 - 2022-08-12August 12, 2022

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