# FDA 483 - bioMerieux, Inc. - April 10, 2017

Source: https://www.keypedia.com/records/483/biomerieux-inc/b2182115-351c-4602-94e0-ebcdd7caac42

> FDA 483 for bioMerieux, Inc. on April 10, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: bioMerieux, Inc.
- Inspection Date: 2017-04-10
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of bioMerieux, Inc. in Durham, NC, a medical device manufacturer, revealed significant deficiencies. The firm's corrective and preventive action (CAPA) procedures were found to be inadequately established, with issues in investigations and effectiveness checks. Additionally, the company failed to clearly define control over products, suppliers, and contractors, specifically regarding agreements for complaint handling and medical device reporting.

## Related Documents

- [483 - 2013-06-14](https://www.keypedia.com/records/483/biomerieux-inc/eb3b9c3a-d6f8-4d33-9979-5220def765b7)
- [483 - 2016-01-05](https://www.keypedia.com/records/483/biomerieux-inc/6146b577-66a8-4808-ace3-ea15193b4e6f)

## Related Officers

- [investigator](https://www.keypedia.com/people/samuel-l-murray/74b03eba-03ee-409b-9394-8e903adf6288)
- [Melanie W Fluharty](https://www.keypedia.com/people/melanie-w-fluharty/e9cc49e7-8e2b-4965-a4ee-8d6be4631f2a)
- [Kyeatta Hdabe](https://www.keypedia.com/people/kyeatta-hdabe/fda9ea37-8466-4388-bc2e-46ba5957fac7)

Company: https://www.keypedia.com/companies/biomerieux-inc/0e90e065-1a28-4743-9958-555322a42a36

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7