# FDA 483 - Servi-Dent Inc. - June 27, 2019

Source: https://www.globalkeysolutions.net/records/483/servi-dent-inc/b6cffdaa-b85a-40eb-ab23-4d1172db3af8

> FDA 483 for Servi-Dent Inc. on June 27, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Servi-Dent Inc.
- Inspection Date: 2019-06-27
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.globalkeysolutions.net/companies/servi-dent-inc/e21e9dd5-9c51-4384-9e6a-e8bab51c8a0b

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6