FDA Inspection
Michigan MedicineMichigan Medicine – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Michigan Medicine, with an inspection on December 14, 2018, issued by the Detroit District Office, covering human drugs.
- Office
- Detroit District Office
- Person
- Emily J. Stoklosa (Issuing Officer)
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ID · 079d42b6-76fd-439c-8277-bbc9ecc1c26f
Inspection Facts
- Inspection number
- 1074709
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
- FDCA 501(a)(2)(A)Disruption of airflow from personnel movement
- FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
- FDCA 501(a)(2)(A)Flow of personnel and materials, facility
- FDCA 501(a)(2)(A)Inadequate sporicidal agents, cleanroom and ISO 5 area
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Other FDA inspections of Michigan Medicine
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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