# FDA 483 - DB Diagnostic Systems Inc. - July 16, 2019

Source: https://www.keypedia.com/records/483/db-diagnostic-systems-inc/4a14e2bf-2859-4c02-9ea2-16e10fa81ba4

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

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## Details

- Record Type: 483
- Company Name: DB Diagnostic Systems Inc.
- Inspection Date: 2019-07-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of BB Diagnostic Systems Inc., a medical device establishment in Juno Beach, FL, revealed significant deficiencies in their quality system. The firm's procedures for supplier qualification, software validation, and finished device acceptance were found to be inadequate. These issues indicate a lack of robust controls over critical operations and product quality.

## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.keypedia.com/companies/db-diagnostic-systems-inc/6f86a3f8-b271-4caf-ba5c-ee52dee53045

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