# FDA 483 - BioTissue Holdings Inc - July 16, 2019

Source: https://www.keypedia.com/records/483/biotissue-holdings-inc/38e35d9e-d50d-415f-8ade-47388627677f

> FDA 483 for BioTissue Holdings Inc on July 16, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BioTissue Holdings Inc
- Inspection Date: 2019-07-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: TissueTech, Inc. in Doral, FL, a medical device manufacturer, received a Form 483 with five observations during an inspection from July 8-16, 2019. The observations primarily concern inadequate procedures for process control, rework, corrective and preventive actions, document control, and medical device reporting. These issues indicate significant deficiencies in the firm's quality system management.

## Related Officers

- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)
- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)

Company: https://www.keypedia.com/companies/biotissue-holdings-inc/2cac95ce-8ef8-451a-aa9d-4d03238d18d8

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