Avera Sacred Heart Hospital/Blood Bank, Yankton, SD – FDA Inspections

Inspection records and compliance data for Avera Sacred Heart Hospital/Blood Bank in Yankton, South Dakota. 4 FDA inspections on record, last inspected September 30, 2019.

Company Profile

This profile covers Avera Sacred Heart Hospital/Blood Bank based in Yankton, South Dakota, United States.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 2
NAI: 2
Form 483s: 0
Warning letters: 0

First inspected January 28, 2011. Last inspected September 30, 2019.

Most cited issue areas

Concurrent documentation1 inspection
Establish, maintain and follow manufacturing SOPs1 inspection
Procedures to be written and followed1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
September 30, 2019	NAI	Biologics · Blood and Blood Products	1103371
November 16, 2016	NAI	Biologics · Blood and Blood Products	993339
November 28, 2012	VAI	Biologics · Blood and Blood Products	809597
January 28, 2011	VAI	Biologics · Blood and Blood Products	708638

FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

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South Dakota Lions Eye Bank, Inc.

Rohlf Medical Inc. dba Biomet North Central

Vitalant

Biotest Pharmaceuticals Corporation

Jeffery A. Henderson, M.D.

BPC Plasma, Inc.

South Dakota Lions Eye and Tissue Bank Inc