# FDA 483 - Beckman Coulter, Inc. - October 28, 2021

Source: https://www.keypedia.com/records/483/beckman-coulter-inc/553ae726-3b45-4e86-8134-741b64eb1699

> FDA 483 for Beckman Coulter, Inc. on October 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beckman Coulter, Inc.
- Inspection Date: 2021-10-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: During an inspection, Beckman Coulter, Inc. in Miami, FL, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures and medical device reporting (MDR). The firm failed to adequately manage a Class I recall related to a manufacturing defect, including not updating CAPA records and servicing affected devices. Additionally, the company did not submit required MDR reports for device malfunctions that could cause serious injury or death.

## Related Documents

- [483 - 2017-10-16](https://www.keypedia.com/records/483/beckman-coulter-inc/7a1c1461-04b3-482f-ac5e-20bffa60d83c)
- [483 - 2017-10-16](https://www.keypedia.com/records/483/beckman-coulter-inc/53416069-8295-4cbb-adda-bbdb2df44758)

## Related Officers

- [investigator](https://www.keypedia.com/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

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

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d