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# Michigan Medicine FDA-483
- URL: https://www.fdaweb.com/michigan-medicine-fda-483/
- Published: 2019-03-06T12:00:00.000Z
- Updated: 2026-09-15T01:10:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143535

FDA has released the FDA-483 issued following a 12/3-12/14/18 inspection at Michigan Medicine, an Ann Arbor, MI, drug compounder producing sterile and non-sterile drug products. The four inspection observations were: 

- failing to disinfect materials or supplies before they enter the aseptic processing areas;
- personnel moved rapidly in the vicinity of instruments, disrupting the airflow and increasing the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area;
- personnel engaged in aseptic processing were observed with exposed hands, exposed wrists, exposed legs, exposed hair, and exposed mouth; and
- the facility was designed and/or operated in a way that permits poor flow of materials.