# FDA 483 - Beckman Coulter, Inc. - October 16, 2017

Source: https://www.globalkeysolutions.net/records/483/beckman-coulter-inc/53416069-8295-4cbb-adda-bbdb2df44758

> FDA 483 for Beckman Coulter, Inc. on October 16, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beckman Coulter, Inc.
- Inspection Date: 2017-10-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Beckman Coulter, Inc. in Miami, FL, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for servicing activities, complaint handling, medical device reporting, and corrective and preventive actions. These failures led to a flow cytometry instrument misconfiguration, resulting in numerous erroneous patient results and delayed reporting of critical information to the FDA.

## Related Documents

- [483 - 2017-10-16](https://www.globalkeysolutions.net/records/483/beckman-coulter-inc/7a1c1461-04b3-482f-ac5e-20bffa60d83c)
- [483 - 2021-10-28](https://www.globalkeysolutions.net/records/483/beckman-coulter-inc/553ae726-3b45-4e86-8134-741b64eb1699)

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/9b3a1a9b-0669-427d-ae51-613657b8cd22

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