FDA Inspection
Sibley Memorial HospitalFDA Inspection 680318 - Sibley Memorial Hospital - September 16, 2010
Record Details
This FDA Inspection record concerns Sibley Memorial Hospital, with an inspection on September 16, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Sibley Memorial Hospital
- Inspection Date
- September 16, 2010
- Product Type
- Biologics
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ID · adbb173f-6a24-4a7c-9def-eb650b6881d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680318
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.171(a)BPDR - procedures
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Sibley Memorial Hospital
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 18, 2009 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Sibley Memorial Hospital
- FDA Inspection 742031 - 2011-07-15
- FDA Inspection 611632 - 2009-09-18
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