Fertility and Advanced Reproductive Medicine at UTSW, Dallas, TX – FDA Inspections

Inspection records and compliance data for Fertility and Advanced Reproductive Medicine at UTSW in Dallas, Texas. 5 FDA inspections on record, 1 Form 483, last inspected December 13, 2023.

Company Profile

This profile covers Fertility and Advanced Reproductive Medicine at UTSW based in Dallas, Texas, United States.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 1
NAI: 4
Form 483s: 1
Warning letters: 0

First inspected February 20, 2009. Last inspected December 13, 2023.

Most cited issue areas

Documentation--determination, by whom, date1 inspection
Donor testing not negative for CD agents1 inspection
Eligibility not required--warning labels1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
December 13, 2023	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1224882
November 8, 2018	NAI	Biologics · Blood and Blood Products	1077600
May 17, 2015	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	930747
May 14, 2012	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	781377
February 20, 2009	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	564477

FDA documents

Form 483s (1)

Form 483s · December 13, 2023

People (2)

Ramon L. Gonzalez-Prieto

Person

Bobbi Miller

Person

Related Companies (10)

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Huntington Reproductive Center Medical Group