FDA Inspection
Munroe Regional Medical Center Clinical LaboratoryMunroe Regional Medical Center Clinical Laboratory – FDA Inspection, Oct 2, 2015
Record Details
This FDA Inspection record concerns Munroe Regional Medical Center Clinical Laboratory, with an inspection on October 2, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 2, 2015
- Product Type
- Biologics
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ID · 5c6c40f2-57cf-4f8b-b51d-b7e7abcb8eae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944907
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Munroe Regional Medical Center Clinical Laboratory
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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