FDA Inspection
Labcorp Early Development Laboratories, Inc.Labcorp Early Development Laboratories, Inc. – FDA Inspection, Apr 11, 2025
Record Details
This FDA Inspection record concerns Labcorp Early Development Laboratories, Inc., with an inspection on April 11, 2025, issued by the Detroit District Office, covering human drugs.
- Inspection Date
- April 11, 2025
- Product Type
- Human Drugs
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ID · 04f230e7-bd3b-48b9-b63b-a24fd3e94dea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1266550
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring: Human Drugs
FDA Citations
3- 21 CFR 58.33(b)Study director: all data recorded and verified
- 21 CFR 58.63(a)Equipment: inspection, cleaning and maintenance
- 21 CFR 58.81(b)SOPs: required
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Other FDA inspections of Labcorp Early Development Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2025 | VAI | Detroit District Office | Drug Quality Assurance |
| July 12, 2024 | VAI | Detroit District Office | Bioresearch Monitoring |
| November 21, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Labcorp Early Development Laboratories, Inc.
- FDA Inspection 1276600 - 2025-07-25
- FDA Inspection 1243623 - 2024-07-12
- FDA Inspection 1113166 - 2019-11-21
- FDA Inspection 963103 - 2016-01-20
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