# FDA 483 - BioTissue Holdings Inc - March 06, 2024

Source: https://www.globalkeysolutions.net/records/483/biotissue-holdings-inc/8e034d96-f219-4a82-baad-4eea63d650e9

> FDA 483 for BioTissue Holdings Inc on March 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioTissue Holdings Inc
- Inspection Date: 2024-03-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: BioTissue Holdings Inc, a medical device manufacturer in Miami, FL, was cited with four observations on a Form 483. The inspection revealed significant failures in submitting Medical Device Reports (MDRs) for serious injuries and device malfunctions, inadequate evaluation of device complaints, and insufficient documentation of corrective and preventive actions. These issues indicate deficiencies in the firm's quality system regarding post-market surveillance and quality control.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.globalkeysolutions.net/companies/biotissue-holdings-inc/20aa910d-82e7-4943-9735-62f7b6bbcf4f

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