# FDA 483 - KweHealth LLC - April 03, 2026

Source: https://www.keypedia.com/records/483/kwehealth-llc/6ac0cd96-82c3-41e3-a42b-6f6320a2c1ae

> FDA 483 for KweHealth LLC on April 03, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KweHealth LLC
- Inspection Date: 2026-04-03
- Product Type: other
- Office Name: Florida District Office
- Summary: An FDA inspection of KweHealth LLC in Alachua, FL, a manufacturer of HCT/Ps, revealed significant deficiencies in their manufacturing and quality control processes. Observations included the pooling of HCT/Ps from multiple donors, inadequate documentation of donor eligibility determinations, and a lack of proper equipment maintenance records. Furthermore, the firm failed to back up electronic quality records and could not provide investigation records for out-of-specification results, raising serious data integrity concerns.

## Related Officers

- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)
- [Steen N. Graham](https://www.keypedia.com/people/steen-n-graham/e0ce4c37-b1f1-4d94-8071-2d89b74975fd)

Company: https://www.keypedia.com/companies/kwehealth-llc/3d8a80a1-8d17-4a73-b535-c0d2d5840f9a

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9