# FDA 483 - Metrex Research, LLC. - May 20, 2022

Source: https://www.globalkeysolutions.net/records/483/metrex-research-llc/a134dcfc-2a10-4ea9-9aaf-2195d92302a3

> FDA 483 for Metrex Research, LLC. on May 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Metrex Research, LLC.
- Inspection Date: 2022-05-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Metrex Research, LLC. in Romulus, MI, was inspected and cited for multiple significant deficiencies in their manufacturing processes for drug products. Key issues include inadequate microbiological testing of non-sterile drug products, unvalidated water system testing, poor computer system controls leading to data integrity concerns, and insufficient equipment maintenance and cleaning validation. These observations indicate a lack of robust quality control and assurance practices.

## Related Officers

- [Brent M. Dehaan](https://www.globalkeysolutions.net/people/brent-m-dehaan/7a6af4a2-2566-48af-b59d-dd59008ff997)
- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)
- [Investigator](https://www.globalkeysolutions.net/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)

Company: https://www.globalkeysolutions.net/companies/metrex-research-llc/2aa9cb41-98dc-4938-9825-53ec5e1632ef

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0