FDA 483 - University Of Michigan Hospital and Health Centers - July 11, 2019
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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.
- Inspection Date
- July 11, 2019
- Product Type
- Biologics
ID · 1db6660f-cfe5-4a37-9b44-d3e857c636d2