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FDA Inspection
•KweHealth LLC•April 3, 2026

KweHealth LLC – FDA Inspection, Apr 3, 2026

Record Details

This FDA Inspection record concerns KweHealth LLC, with an inspection on April 3, 2026, issued by the Florida District Office, covering biologics.

Company
KweHealth LLC
Inspection Date
April 3, 2026
Product Type
Biologics
Office
Florida District Office
People
  • Mizanne E. Lewis (Company Rep)
  • Steen N. Graham (Issuing Officer)
View Company Profile

ID · 934fc2f9-f578-44cb-9faf-4c7e5c787783

Inspection Facts

Inspection number
1292494
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

4
  1. 21 CFR 1271.200(e)Documentation of maintenance and cleaning
  2. 21 CFR 1271.220(b)Pooling from two or more donors
  3. 21 CFR 1271.270(c)Back-up of electronic records
  4. 21 CFR 1271.50(a)Responsible person to determine, document

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