FDA Inspection
Delta County Memorial Hospital Blood BankDelta County Memorial Hospital Blood Bank – FDA Inspection, Aug 22, 2016
Record Details
This FDA Inspection record concerns Delta County Memorial Hospital Blood Bank, with an inspection on August 22, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 22, 2016
- Product Type
- Biologics
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ID · e1e74c36-ad59-46e1-af32-6bb31d5334fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986270
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(d)Retention period
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Delta County Memorial Hospital Blood Bank
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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