# FDA 483 - Inter Bio-Lab, Inc. - December 05, 2019

Source: https://www.keypedia.com/records/483/inter-bio-lab-inc/c14f6130-98e6-45ae-bcf1-d9f046103fb1

> FDA 483 for Inter Bio-Lab, Inc. on December 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inter Bio-Lab, Inc.
- Inspection Date: 2019-12-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Inter Bio-Lab, Inc., a medical device manufacturer in Orlando, FL, was cited for three observations related to inadequate complaint handling and Medical Device Reporting (MDR) procedures. The firm lacked established written procedures for managing complaints, failed to investigate device failure complaints, and did not maintain adequate written MDR procedures. These issues indicate significant deficiencies in their quality system for post-market surveillance.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/inter-bio-lab-inc/10e3dea8-4824-4655-bd9c-c3e537dffc9e

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