Company
United StatesKLEB Inc, Louisville, KY – FDA Inspections
Inspection records and compliance data for KLEB Inc in Louisville, Kentucky. 7 FDA inspections on record, 1 Form 483, last inspected March 17, 2026.
Company Profile
This profile covers KLEB Inc based in Louisville, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 0
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 2, 2009. Last inspected March 17, 2026.
Most cited issue areas
- Documentation of maintenance and cleaning1 inspection
- Donors with risks not determined ineligible1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2026 | Not classified | Biologics · Human Cellular, Tissue, and Gene Therapies | 1308704 |
| August 24, 2023 | NAI | Biologics · Blood and Blood Products | 1216491 |
| July 28, 2021 | NAI | Biologics · Vaccines and Allergenic Products | 1148296 |
| February 7, 2018 | NAI | Biologics · Blood and Blood Products | 1040736 |
| February 10, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 957586 |
| June 18, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 837858 |
| December 2, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 631306 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
KLEB Inc
FEI Number
3013157033
Address
10160 Linn Station Rd, Louisville, Kentucky 40223, United States
Country
United States
ID: 4a2a949f-8893-4a4c-afd4-87e1adea1607