483
Servi-Dent Inc.Servi-Dent Inc. – FDA 483, Jun 27, 2019
Record Details
Servi-Dent Inc., a human tissue distributor in Miami, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked fundamental procedures for complaint handling, receipt and distribution of human tissue products, and the acceptance of returned HCT/Ps. Additionally, the firm failed to monitor or record storage temperatures for HCT/Ps.
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ID · b6cffdaa-b85a-40eb-ab23-4d1172db3af8
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