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FDA Inspection
•St Agnes Healthcare Blood Bank•July 17, 2009

St Agnes Healthcare Blood Bank – FDA Inspection, Jul 17, 2009

Record Details

This FDA Inspection record concerns St Agnes Healthcare Blood Bank, with an inspection on July 17, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
St Agnes Healthcare Blood Bank
Inspection Date
July 17, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 95d749ce-b1ac-4ed0-8a93-054f18fa4af5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
597679
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.100(b)Written SOPs available for use by personnel
  2. 21 CFR 600.80(c)(2)(ii)Reporting Requirement - Periodic adv. exp. report content

Full citation text and observation details available on the Dashboard.

Other FDA inspections of St Agnes Healthcare Blood Bank

1
DateClassificationOfficeProject area
February 4, 2011VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for St Agnes Healthcare Blood Bank
  • FDA Inspection 709598 - 2011-02-04

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