483
Exactech, Inc.FDA 483 - Exactech, Inc. - August 22, 2003
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Record Details
Exactech, Inc., a human tissue establishment in Gainesville, FL, was cited for failing to ensure tissue suitable for transplantation was accompanied by complete donor records. The firm did not receive or maintain relevant donor medical records and had not audited its tissue suppliers since 2000. This indicates significant deficiencies in record-keeping and supplier oversight for tissue safety.
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ID · 62f74277-82d6-4797-9cd6-55611e71e194