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# University of Michigan Gets 8-item 483 After June Inspection
- URL: https://www.fdaweb.com/university-of-michigan-gets-8-item-483-after-june-inspection/
- Published: 2016-08-01T12:00:00.000Z
- Updated: 2026-09-14T21:20:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136351

FDA has issued the University of Michigan an eight-observation Form-483 about pharmacy compounding violations it observed during a June inspection. The document said university investigations into batch failures did not extend to other drug products that may have been associated with the specific discrepancy/failure. The agency also cited the institution for inadequate procedures to prevent microbiological contamination, and for having deficient aseptic processing areas. To view the Form 483, click [here](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm513789.pdf?ref=fdaweb.com).