# FDA 483 - Cambridge Diagnostic Products, Inc. - March 16, 2023

Source: https://www.keypedia.com/records/483/cambridge-diagnostic-products-inc/cba75e4e-5c5d-4641-acbc-95055a6d2133

> FDA 483 for Cambridge Diagnostic Products, Inc. on March 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambridge Diagnostic Products, Inc.
- Inspection Date: 2023-03-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cambridge Diagnostic Products, Inc. in Ft Lauderdale, FL, a medical device manufacturer, was inspected and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in their quality system, including inadequate complaint handling, medical device reporting, equipment calibration, contractor evaluation, and internal quality audit procedures. These issues indicate a systemic lack of adherence to quality system regulations.

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/cambridge-diagnostic-products-inc/ee9b8d32-0ef6-4915-91e4-915ee72bf41e

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