FDA Inspection
Labcorp Bedford LLC.Labcorp Bedford LLC. – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns Labcorp Bedford LLC., with an inspection on July 21, 2017, issued by the New England District Office, covering human drugs.
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ID · 8d9b8fad-08cc-4da5-b24b-14691d1975d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018680
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 58.130(e)Conduct: changes not obscuring original entries
- 21 CFR 58.29(a)Personnel: education, training, experience
- 21 CFR 58.33(b)Study director: all data recorded and verified
- 21 CFR 58.33(c)Study director: unforeseen circumstances
- 21 CFR 58.35(b)(5)QAU: authorize deviations from protocols or SOPs
- 21 CFR 58.35(b)(7)QAU: signed statement in final report
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Other FDA inspections of Labcorp Bedford LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2025 | Not classified | New England District Office | |
| January 24, 2019 | VAI | New England District Office | Human Cellular, Tissue, and Gene Therapies |
Other documents for Labcorp Bedford LLC.
- FDA Inspection 1271033 - 2025-04-25
- FDA Inspection 1077296 - 2019-01-24
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