Servi-Dent Inc.June 27, 2019

FDA 483 - Servi-Dent Inc. - June 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.

Company: Servi-Dent Inc.
Inspection Date: June 27, 2019
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
Person: Barbara T. Carmichael (Investigator at U.S.FDA)

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ID · b6cffdaa-b85a-40eb-ab23-4d1172db3af8