FDA Inspection
Labcorp Early Development Laboratories, Inc.Labcorp Early Development Laboratories, Inc. – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns Labcorp Early Development Laboratories, Inc., with an inspection on August 17, 2018, issued by the Minneapolis District Office, covering human drugs.
- Inspection Date
- August 17, 2018
- Product Type
- Human Drugs
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ID · 14199cc0-0360-4330-bc9b-cf239b25d81c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064823
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 58.45Facility: supply storage areas
- 21 CFR 58.63(a)Equipment: calibration
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Other FDA inspections of Labcorp Early Development Laboratories, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2025 | VAI | Minneapolis District Office | Human Cellular, Tissue, and Gene Therapies |
| August 30, 2023 | VAI | Minneapolis District Office | |
| February 14, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 5, 2019 | Not classified | Minneapolis District Office | |
| August 24, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Labcorp Early Development Laboratories, Inc.
- FDA Inspection 1269784 - 2025-05-07
- FDA Inspection 1216326 - 2023-08-30
- FDA Inspection 1121677 - 2020-02-14
- FDA Inspection 1106741 - 2019-09-05
- FDA Inspection 1065286 - 2018-08-24
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