FDA 483 - KweHealth LLC - April 03, 2026
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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.
ID · 6ac0cd96-82c3-41e3-a42b-6f6320a2c1ae