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

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.