483
Scantibodies Laboratory, Inc.Scantibodies Laboratory, Inc. – FDA 483, Jul 2, 2026
Record Details
Scantibodies Laboratory, Inc. in Santee, CA, was cited for failing to determine donor eligibility before collecting source plasma during an inspection from June 29 to July 2, 2026. The firm collected plasma without valid informed consent or completed donor history questionnaires, indicating a significant lapse in donor screening procedures. This issue affected numerous donations over several years, impacting products for devices.
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ID · 07daa7d2-6891-4faf-bd0d-2a237d7c3c59
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