FDA Inspection
Bergen Comm. Reg. Blood Ctr. Dba Community Blood ServicesBergen Comm. Reg. Blood Ctr. Dba Community Blood Services – FDA Inspection, Mar 24, 2010
Record Details
This FDA Inspection record concerns Bergen Comm. Reg. Blood Ctr. Dba Community Blood Services, with an inspection on March 24, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 24, 2010
- Product Type
- Biologics
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ID · c87f062f-458c-4b5c-b8ce-7c400a930d21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652076
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Bergen Comm. Reg. Blood Ctr. Dba Community Blood Services
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bergen Comm. Reg. Blood Ctr. Dba Community Blood Services
- FDA Inspection 795394 - 2012-08-21
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