FDA Inspection
KLEB, IncKLEB, Inc – FDA Inspection, Sep 14, 2026
Record Details
This FDA Inspection record concerns KLEB, Inc, with an inspection on September 14, 2026, issued by the Cincinnati District Office, covering biologics.
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ID · 8ca4207e-8f6b-419c-8926-0fdf994c05d1
Inspection Facts
- Inspection number
- 1335600
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of KLEB, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 19, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 8, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 30, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 9, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for KLEB, Inc
- FDA Inspection 1163378 - 2022-02-23
- FDA Inspection 1076519 - 2018-12-19
- FDA Inspection 993737 - 2016-12-08
- FDA Inspection 902025 - 2014-10-30
- FDA Inspection 806766 - 2012-11-09
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