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University of Louisville Physicians OBGYN & Womens Health Fertility Center, Louisville, KY – FDA Inspections

Inspection records and compliance data for University of Louisville Physicians OBGYN & Womens Health Fertility Center in Louisville, Kentucky. 4 FDA inspections on record, 1 Form 483, last inspected July 14, 2017.

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Company Profile

This profile covers University of Louisville Physicians OBGYN & Womens Health Fertility Center based in Louisville, Kentucky, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
1
NAI
3
Form 483s
1
Warning letters
0

First inspected September 13, 2010. Last inspected July 14, 2017.

Most cited issue areas

  • Responsible person to determine, document2 inspections
  • Abbreviated procedure1 inspection
  • Design adequate to bar spread of CD"s1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
July 14, 2017NAIBiologics · Blood and Blood Products1018102
November 19, 2014NAIBiologics · Human Cellular, Tissue, and Gene Therapies904244
November 2, 2012NAIBiologics · Human Cellular, Tissue, and Gene Therapies805996
September 13, 2010VAIBiologics · Human Cellular, Tissue, and Gene Therapies681455
FDA documents

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

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James Hedrick, MD
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Kentucky Blood Center Inc
Clark Medical
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Company Information

Name

University of Louisville Physicians OBGYN & Womens Health Fertility Center

FEI Number

3004557180

Address

401 E Chestnut St Unit 410, Louisville, Kentucky 40202, United States

Country

United States

ID: 1744e14c-a083-4f4d-82fd-3e65d127a85d

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