# FDA 483 - bioMerieux, Inc. - January 05, 2016

Source: https://www.keypedia.com/records/483/biomerieux-inc/6146b577-66a8-4808-ace3-ea15193b4e6f

> FDA 483 for bioMerieux, Inc. on January 05, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: bioMerieux, Inc.
- Inspection Date: 2016-01-05
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of bioMerieux, Inc. in Durham, NC, a manufacturer of culture media products, revealed numerous deficiencies across its quality management system. Observations included inadequate complaint evaluations, unreported field corrective actions, unsupported raw material expiration dating, and significant issues with environmental monitoring, equipment maintenance, and calibration. Furthermore, the firm demonstrated systemic failures in personnel training, documentation control, product handling reconciliation, and quality audit procedures.

## Related Documents

- [483 - 2013-06-14](https://www.keypedia.com/records/483/biomerieux-inc/eb3b9c3a-d6f8-4d33-9979-5220def765b7)
- [483 - 2017-04-10](https://www.keypedia.com/records/483/biomerieux-inc/b2182115-351c-4602-94e0-ebcdd7caac42)

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)
- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)
- [investigator](https://www.keypedia.com/people/samuel-l-murray/74b03eba-03ee-409b-9394-8e903adf6288)
- [investigator](https://www.keypedia.com/people/sayeeda-hdabe/eaadc7cf-5f22-47c2-ba02-437efe0a5267)

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