# FDA WARNING_LETTER - Biomerieux, Inc. - March 06, 2012

Source: https://www.keypedia.com/records/warning_letter/biomerieux-inc/28092549-e8ab-4331-b946-bee53058067f

> FDA WARNING_LETTER for Biomerieux, Inc. on March 06, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Biomerieux, Inc.
- Inspection Date: 2012-03-06
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On August 23, 2012, the FDA issued a Warning Letter to bioMerieux, Inc. following an inspection from January 24 to March 06, 2012, at their Durham, NC facility. The inspection revealed that the firm's in vitro diagnostic devices are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulations (21 CFR Part 820).

Key violations include:
1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)):** This was evidenced by numerous non-conformances and recurring issues with BacT/ALERT production lots (e.g., low [b][4], faulty bottle seams, false positives), with inadequate or unverified corrective actions.
2. **Failure to adequately validate and document processes (21 CFR 820.75(a)):** Specifically, Line 1B BacT/ALERT validation activities were incomplete and lacked sufficient data.
3. **Failure to control non-conforming product (21 CFR 820.90(a)):** No documentation for rework of a large quantity of BacT/ALERT SN Lot 1030140 for [

## Related Officers

- [Marc Mackowiak](https://www.keypedia.com/people/marc-mackowiak/2aa344c3-d6ab-4193-a8ac-290cbca915fd)
- [John R. Gridley](https://www.keypedia.com/people/john-r-gridley/32a64db5-8914-4eb2-93ea-e41da190edd7)

Company: https://www.keypedia.com/companies/biomerieux-inc/9cb36940-306d-48c4-af55-3995ed532955

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861