FDA Inspection
Laboratory Corporation of AmericaLaboratory Corporation of America – FDA Inspection, Jun 19, 2017
Record Details
This FDA Inspection record concerns Laboratory Corporation of America, with an inspection on June 19, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6d073e0d-d97e-43ed-97a3-4c27d590a7c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014745
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Laboratory Corporation of America
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 2, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 8, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 23, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Laboratory Corporation of America
- FDA Inspection 1092969 - 2019-05-15
- FDA Inspection 933303 - 2015-07-02
- FDA Inspection 821423 - 2013-03-08
- FDA Inspection 718583 - 2011-03-23
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