Inspection Record

Michigan Medicine — FDA 483 Findings

US FDAInspected 2018-12-14Published 2019-04-30 4 findingsAseptic processing and sterility assuranceEquipment and facility

Inspectors Emily J OrbanThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic processing and sterility assurance

Personnel moved rapidly in the vicinity of instrnments, which disrnpted the airflow and increased the risk ofbringing lesser quality air into the ISO 5 classified aseptic processing area.

2Equipment and facility

Your facility was designed and/or operated in a way that perm.its poor flow of mate1ials.

3Aseptic processing and sterility assurance

Materials or supplies were not disinfected prior to entering the aseptic processing areas.

4Aseptic processing and sterility assurance

Personnel engaged in aseptic processing were observed with exposed hands, exposed wrists, exposed legs, exposed hair and exposed mouth.

About this record

Extracted automatically from the document US FDA published on 2019-04-30. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Michigan Medicine company profile — full history US FDA documents, 2019 Go to Findings search