# FDA 483 - University Of Michigan Hospital and Health Centers - July 11, 2019

Source: https://www.globalkeysolutions.net/records/483/university-of-michigan-hospital-and-health-centers/1db6660f-cfe5-4a37-9b44-d3e857c636d2

> FDA 483 for University Of Michigan Hospital and Health Centers on July 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Of Michigan Hospital and Health Centers
- Inspection Date: 2019-07-11
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: During an inspection, the University of Michigan Hospitals - Clinical Micro was cited for four observations related to its microbiology laboratory operations. Issues included a failure to revalidate a sterility sample culture testing process after a significant relocation, lack of documented cleaning for an incubator used for HCT/P sterility samples, and deficiencies in records management for equipment maintenance. Additionally, the firm lacked established cleaning procedures for critical equipment.

## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Erma Zaimova](https://www.globalkeysolutions.net/people/erma-zaimova/87da23ad-48bb-4096-9d8a-e8511c6b5c98)

Company: https://www.globalkeysolutions.net/companies/university-of-michigan-hospital-and-health-centers/264a43b1-c910-4714-9591-1db5f208ada5

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