HCSC-Blood Center, Bethlehem, PA – FDA Inspections

Inspection records and compliance data for HCSC-Blood Center in Bethlehem, Pennsylvania. 8 FDA inspections on record, 1 Form 483, last inspected July 20, 2026.

Company Profile

This profile covers HCSC-Blood Center based in Bethlehem, Pennsylvania, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 0
NAI: 7
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected March 5, 2010. Last inspected July 20, 2026.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs1 inspection
Required records1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
July 20, 2026	Not classified	Biologics · Blood and Blood Products	1327046
June 16, 2023	NAI	Biologics · Blood and Blood Products	1209789
February 21, 2020	NAI	Biologics · Blood and Blood Products	1121127
March 15, 2018	NAI	Biologics · Blood and Blood Products	1046306
March 1, 2016	NAI	Biologics · Blood and Blood Products	963579
February 12, 2014	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	865598
March 1, 2012	NAI	Biologics · Blood and Blood Products	770117
March 5, 2010	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	650202

FDA documents

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

Related Companies (10)

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

Biological Specialty Corp

Memorial Medical Center

CSL Plasma Inc

American National Red Cross

Patterson Logistics Services Inc.

Central Pennsylvania Blood Bank

The Midwife Center for Birth & Women"s Health

Institute for Transfusion Medicine Clinical Services

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CHOP King of Prussia Hospital Blood Bank