FDA Inspection
Labcorp Early Development Laboratories, Inc.Labcorp Early Development Laboratories, Inc. – FDA Inspection, Jul 12, 2024
Record Details
This FDA Inspection record concerns Labcorp Early Development Laboratories, Inc., with an inspection on July 12, 2024, issued by the Detroit District Office, covering human drugs.
- Inspection Date
- July 12, 2024
- Product Type
- Human Drugs
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ID · 0d0d9918-74f6-41b2-b2c8-003cf0227bde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243623
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 58.185(a)(10)Final report: names of those involved
- 21 CFR 58.33(f)Study director: transfer of data to archives
- 21 CFR 58.35(b)(1)QAU: maintain a master schedule
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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 |
| April 11, 2025 | VAI | Detroit District Office | Bioresearch Monitoring: Human Drugs |
| 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 1266550 - 2025-04-11
- FDA Inspection 1113166 - 2019-11-21
- FDA Inspection 963103 - 2016-01-20
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