# FDA 483 - Luminex Corporation - February 14, 2020

Source: https://www.keypedia.com/records/483/luminex-corporation/221264e9-df77-4e42-b781-44d51e5e60a4

> FDA 483 for Luminex Corporation on February 14, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luminex Corporation
- Inspection Date: 2020-02-14
- Product Type: device
- Office Name: Chicago District Office
- Summary: Luminex Corporation, a medical device manufacturer in Northbrook, IL, was cited for four observations related to its quality system. The inspection revealed deficiencies in corrective and preventive actions, process validation, reporting of device removals, and monitoring of validated process parameters for its Verigene SP instruments. These issues indicate a lack of adherence to established procedures and regulatory expectations for medical device quality management.

## Related Documents

- [WARNING_LETTER - 2020-02-14](https://www.keypedia.com/records/warning_letter/luminex-corporation/02b42ede-af22-4ce1-ba03-0e0f48ac82d3)
- [483 - 2021-10-22](https://www.keypedia.com/records/483/luminex-corporation/269aaf2d-c120-43cc-a6a8-ed91fe724725)
- [EIR - 2023-01-20](https://www.keypedia.com/records/eir/luminex-corporation/da1d5c99-6d34-4f55-9d5f-57544e9bef7a)
- [483 - 2023-01-20](https://www.keypedia.com/records/483/luminex-corporation/28d8ccac-6815-4b4b-9fa0-23d265e28e06)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [Vladimir Wolf](https://www.keypedia.com/people/vladimir-wolf/5b21c9d2-50d2-4f13-a874-7b2f5c58e4be)

Company: https://www.keypedia.com/companies/luminex-corporation/55525767-0124-4f84-8e09-0a8d7b03947e

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669