# FDA 483 - Biomerieux Inc - August 20, 2019

Source: https://www.keypedia.com/records/483/biomerieux-inc/7225d3cb-a4ab-43a9-9fe4-845a7316aa89

> FDA 483 for Biomerieux Inc on August 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomerieux Inc
- Inspection Date: 2019-08-20
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Biomerieux Inc. in Hazelwood, MO, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in the firm's post-market risk analysis process, which failed to adequately incorporate post-market data. Additionally, the firm was cited for failing to submit Medical Device Reports (MDRs) within the required 30-day timeframe for device malfunctions.

## Related Documents

- [WARNING_LETTER - 2014-07-30](https://www.keypedia.com/records/warning_letter/biomerieux-inc/27d2d192-fad8-42d8-b27e-1fb9fbd493af)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/joseph-d-gong/c1079a56-5f84-4e0d-9f76-9dc1187e588a)
- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/biomerieux-inc/4ca56fd6-0bcf-4144-8cb6-60511d8260b4

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