FDA Inspection
Cuyuna Regional Medical CenterCuyuna Regional Medical Center – FDA Inspection, Jun 19, 2013
Record Details
This FDA Inspection record concerns Cuyuna Regional Medical Center, with an inspection on June 19, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 19, 2013
- Product Type
- Biologics
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ID · d53ba18e-25f1-4381-8734-b01c17db8df5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838224
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Cuyuna Regional Medical Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 12, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Cuyuna Regional Medical Center
- FDA Inspection 730718 - 2011-06-13
- FDA Inspection 588998 - 2009-05-12
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