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FDA Inspection
•Western Kentucky Regional Blood Ctr•January 14, 2014

Western Kentucky Regional Blood Ctr – FDA Inspection, Jan 14, 2014

Record Details

This FDA Inspection record concerns Western Kentucky Regional Blood Ctr, with an inspection on January 14, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Western Kentucky Regional Blood Ctr
Inspection Date
January 14, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · fa0bdafe-3d91-4d25-b015-204aa4f5a3a2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
865140
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

4
  1. 21 CFR 606.60(a)Provide proper equipment to meet requirements
  2. 21 CFR 606.40Clean & orderly
  3. 21 CFR 606.65(e)Following manufacturer"s instructions
  4. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Western Kentucky Regional Blood Ctr

6
DateClassificationOfficeProject area
March 24, 2026NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 30, 2021NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 6, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 9, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 27, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Western Kentucky Regional Blood Ctr
  • FDA Inspection 1309978 - 2026-03-24
  • FDA Inspection 1153258 - 2021-08-30
  • FDA Inspection 1055333 - 2018-06-06
  • FDA Inspection 962499 - 2016-03-09
  • FDA Inspection 752020 - 2011-10-27

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