University Of Michigan Hospitals – Clinical Micro in Ann Arbor, Michigan was inspected by the Food and Drug Administration (FDA) on July 11 for human cellular, tissue, and gene therapies and received four citations, according to data posted on the FDA’s official website.
The FDA website indicates that the citations were delivered to the company as follows:
‘Equipment used for manufacturing HCT/Ps was not cleaned according to established schedules.’
‘Procedures for the cleaning of equipment were not established.’
‘A validated process that was changed was not revalidated.’
‘The records management system was not designed to ensure that records stored in more than one location can be promptly identified and retrieved.’
The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.
The FDA is a government agency that is primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
