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FDA Inspection
•Murray - Calloway County Public Hospital Corp•December 20, 2017

Murray - Calloway County Public Hospital Corp – FDA Inspection, Dec 20, 2017

Record Details

This FDA Inspection record concerns Murray - Calloway County Public Hospital Corp, with an inspection on December 20, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Murray - Calloway County Public Hospital Corp
Inspection Date
December 20, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Leena Thomas (Company Rep)
View Company Profile

ID · a293cdb6-d316-4668-a1d2-b5e678ab3737

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1035626
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 610.40(a)(2)Test for HTLV, syphilis, West Nile, Chagas
  2. 21 CFR 606.100(b)(14)QC procedures for supplies and reagents

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Murray - Calloway County Public Hospital Corp

5
DateClassificationOfficeProject area
January 11, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 28, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 5, 2013VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 17, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 5, 2009NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Murray - Calloway County Public Hospital Corp
  • FDA Inspection 1196687 - 2023-01-11
  • FDA Inspection 947866 - 2015-10-28
  • FDA Inspection 858277 - 2013-12-05
  • FDA Inspection 755808 - 2011-11-17
  • FDA Inspection 629919 - 2009-11-05

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