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FDA Inspection
•Valley View Hospital Blood Bank•May 26, 2010

Valley View Hospital Blood Bank – FDA Inspection, May 26, 2010

Record Details

This FDA Inspection record concerns Valley View Hospital Blood Bank, with an inspection on May 26, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Valley View Hospital Blood Bank
Inspection Date
May 26, 2010
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 45ecdf5b-0e28-4da2-b05e-f338fdd87be3

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
665356
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

7
  1. 21 CFR 606.160(e)(1)Donor deferral record - each location
  2. 21 CFR 630.40(d)(2)Notification
  3. 21 CFR 630.40(c)Notification w/in 8 weeks
  4. 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
  5. 21 CFR 640.5(e)Testing - inspection
  6. 21 CFR 211.194(a)(8)Second person sign off
  7. 21 CFR 640.4(f)Arm preparation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Valley View Hospital Blood Bank

2
DateClassificationOfficeProject area
June 23, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 20, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Valley View Hospital Blood Bank
  • FDA Inspection 980169 - 2016-06-23
  • FDA Inspection 915298 - 2015-02-20

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