# FDA 483 - bioMerieux, Inc. - June 14, 2013

Source: https://www.globalkeysolutions.net/records/483/biomerieux-inc/eb3b9c3a-d6f8-4d33-9979-5220def765b7

> FDA 483 for bioMerieux, Inc. on June 14, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: bioMerieux, Inc.
- Inspection Date: 2013-06-14
- Product Type: device
- Office Name: Atlanta District Office
- Summary: bioMerieux, Inc. in Durham, NC, a medical device manufacturer of blood culture bottles, was cited for significant deficiencies across its quality system. The inspection revealed inadequate production process controls, failures in handling nonconforming products, and widespread issues with process validation and corrective and preventive actions. Additionally, the firm demonstrated shortcomings in design control documentation, complaint investigations, and personnel training.

## Related Documents

- [483 - 2016-01-05](https://www.globalkeysolutions.net/records/483/biomerieux-inc/6146b577-66a8-4808-ace3-ea15193b4e6f)
- [483 - 2017-04-10](https://www.globalkeysolutions.net/records/483/biomerieux-inc/b2182115-351c-4602-94e0-ebcdd7caac42)

## Related Officers

- [Misty Dmeza](https://www.globalkeysolutions.net/people/misty-dmeza/020756e8-60f0-415f-9b4a-46e0cb06a411)
- [Vascular Neurologist/Neurohospitalist/Medical Officer](https://www.globalkeysolutions.net/people/claudette-d-brooks/10f30b8f-2d20-4f92-84c1-862b31b81ce1)
- [Trang N. Cox](https://www.globalkeysolutions.net/people/trang-n-cox/436825b5-0375-4191-81b9-6e18b90d33af)
- [Sean T. Creighton](https://www.globalkeysolutions.net/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)

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

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