FDA Inspection
KLEB IncKLEB Inc – FDA Inspection, Mar 17, 2026
Record Details
This FDA Inspection record concerns KLEB Inc, with an inspection on March 17, 2026, issued by the Cincinnati District Office, covering biologics.
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ID · e5e971ef-a499-4485-b079-21ef6776ff9d
Inspection Facts
- Inspection number
- 1308704
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
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Other FDA inspections of KLEB Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 7, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 18, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for KLEB Inc
- FDA Inspection 1216491 - 2023-08-24
- FDA Inspection 1148296 - 2021-07-28
- FDA Inspection 1040736 - 2018-02-07
- FDA Inspection 957586 - 2016-02-10
- FDA Inspection 837858 - 2013-06-18
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