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FDA Inspection
•Labcorp Early Development Laboratories, Inc.•May 7, 2025

Labcorp Early Development Laboratories, Inc. – FDA Inspection, May 7, 2025

Record Details

This FDA Inspection record concerns Labcorp Early Development Laboratories, Inc., with an inspection on May 7, 2025, issued by the Minneapolis District Office, covering biologics.

Company
Labcorp Early Development Laboratories, Inc.
Inspection Date
May 7, 2025
Product Type
Biologics
Office
Minneapolis District Office
People
  • Carmen Y. Fisher (FDA Associated Person)
  • Isabel Y. Espinosa (FDA Associated Person)
View Company Profile

ID · 03baebe6-56aa-43ed-98d2-19c66733b02b

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1269784
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 58.33(f)Study director: transfer of data to archives

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Labcorp Early Development Laboratories, Inc.

8
DateClassificationOfficeProject area
August 30, 2023VAIMinneapolis District Office
February 14, 2020NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
September 5, 2019Not classifiedMinneapolis District Office
August 24, 2018VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
August 17, 2018VAIMinneapolis District OfficeBioresearch Monitoring
View all 8 other inspections on the company page
Other documents for Labcorp Early Development Laboratories, Inc.
  • FDA Inspection 1216326 - 2023-08-30
  • FDA Inspection 1121677 - 2020-02-14
  • FDA Inspection 1106741 - 2019-09-05
  • FDA Inspection 1065286 - 2018-08-24
  • FDA Inspection 1064823 - 2018-08-17

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