FDA Inspection
White Plains Hospital Center Blood BankWhite Plains Hospital Center Blood Bank – FDA Inspection, Nov 23, 2009
Record Details
This FDA Inspection record concerns White Plains Hospital Center Blood Bank, with an inspection on November 23, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 23, 2009
- Product Type
- Biologics
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ID · 675a0dfe-0366-452c-992d-ba5cae462aec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628713
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.171(a)BPDR - procedures
- 21 CFR 606.160(b)Required records
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 211.192No written record of investigation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of White Plains Hospital Center Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2026 | Not classified | New York District Office | |
| August 9, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 10, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 25, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 21, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for White Plains Hospital Center Blood Bank
- FDA Inspection 1311738 - 2026-03-13
- FDA Inspection 1065518 - 2018-08-09
- FDA Inspection 983498 - 2016-08-10
- FDA Inspection 887265 - 2014-07-25
- FDA Inspection 799087 - 2012-09-21
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