# FDA 483 - Labcorp Early Development Laboratories, Inc. - August 30, 2023

Source: https://www.keypedia.com/records/483/labcorp-early-development-laboratories-inc/cd64e393-af0e-4c02-87de-15efb9702ca0

> FDA 483 for Labcorp Early Development Laboratories, Inc. on August 30, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Labcorp Early Development Laboratories, Inc.
- Inspection Date: 2023-08-30
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Labcorp Early Development Laboratories, Inc. in Madison, WI, revealed significant deficiencies in nonclinical laboratory practices. Observations included failures in periodic analysis and timely notification for animal drinking water contaminants, the inability to retain raw data for a nonclinical study, and the study director's failure to ensure protocol adherence and update changes. These issues indicate a lack of control over critical aspects of nonclinical studies and animal welfare.

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Company: https://www.keypedia.com/companies/labcorp-early-development-laboratories-inc/fd7a8136-483e-4368-bbf9-d12f2e2ca1f2

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d