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•United States

Reading Hospital, West Reading, PA – FDA Inspections

Inspection records and compliance data for Reading Hospital in West Reading, Pennsylvania. 9 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 30, 2025.

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Company Profile

This profile covers Reading Hospital based in West Reading, Pennsylvania, United States.

FDA Inspection History

FDA inspections
9
OAI
1
VAI
1
NAI
7
Form 483s
1
Warning letters
0

First inspected November 13, 2008. Last inspected July 30, 2025.

Most cited issue areas

  • Event files -- failure to establish and maintain1 inspection
  • Info evaluated to determine if event was reportable1 inspection
  • Lack of System for Determining MDR Events1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
July 30, 2025VAIBiologics · Blood and Blood Products1277001
May 11, 2022NAIBiologics · Blood and Blood Products1170357
November 29, 2017NAIBiologics · Blood and Blood Products1035060
January 19, 2016NAIBiologics · Blood and Blood Products956401
December 16, 2015OAIMedical Devices & Rad Health · Postmarket Assurance: Devices953641
February 20, 2014NAIBiologics · Human Cellular, Tissue, and Gene Therapies866734
June 14, 2012NAIBiologics · Human Cellular, Tissue, and Gene Therapies786471
August 18, 2010NAIBiologics · Human Cellular, Tissue, and Gene Therapies676353
November 13, 2008NAIBiologics · Blood and Blood Products546831
FDA documents

Form 483s (2)

  • Form 483s · July 30, 2025
  • Form 483s · December 16, 2015
People (4)
Edward D. McDonald
Person
Edward D. Medon
Person
Emily A. Walters
Person
Michele Gottshall
Person
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Company Information

Name

Reading Hospital

FEI Number

2571104

Address

420 S 5th Ave, West Reading, Pennsylvania 19611, United States

Country

United States

ID: 06325159-9820-479a-ba2e-0f47aaa24d60

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