FDA Inspection
Bergen Comm Reg Blood CenterBergen Comm Reg Blood Center – FDA Inspection, Mar 14, 2012
Record Details
This FDA Inspection record concerns Bergen Comm Reg Blood Center, with an inspection on March 14, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Bergen Comm Reg Blood Center
- Inspection Date
- March 14, 2012
- Product Type
- Biologics
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ID · 0173aa15-1476-4a70-acaa-1116bd150541
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773806
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)(4)Relate products to the donor
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Bergen Comm Reg Blood Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 25, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 4, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 31, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 19, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bergen Comm Reg Blood Center
- FDA Inspection 1326740 - 2026-07-10
- FDA Inspection 1196618 - 2023-01-25
- FDA Inspection 1078963 - 2019-02-04
- FDA Inspection 1009279 - 2017-03-31
- FDA Inspection 978304 - 2016-07-19
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