United Therapeutics Corporation (NASDAQ: UTHR), Silver Spring, MD – FDA Inspections

Inspection records and compliance data for United Therapeutics Corporation in Silver Spring, Maryland. 8 FDA inspections on record, 1 Form 483, last inspected May 02, 2024. Publicly traded as NASDAQ: UTHR.

Company Profile

This profile covers United Therapeutics Corporation based in Silver Spring, Maryland, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 5
NAI: 3
Form 483s: 1
Warning letters: 0

First inspected November 7, 2008. Last inspected May 2, 2024.

Most cited issue areas

Investigations of discrepancies, failures2 inspections
Computer control of master formula records1 inspection
GMP Training Frequency1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
May 2, 2024	VAI	Human Drugs · Drug Quality Assurance	1230507
March 31, 2017	VAI	Human Drugs · Drug Quality Assurance	1031503
July 11, 2014	NAI	Human Drugs · Drug Quality Assurance	890759
May 29, 2013	VAI	Human Drugs · Drug Quality Assurance	832855
December 12, 2011	NAI	Human Drugs · Bioresearch Monitoring	756694
June 28, 2011	NAI	Human Drugs · Drug Quality Assurance	732085
February 11, 2011	VAI	Human Drugs · Drug Quality Assurance	709171
November 7, 2008	VAI	Human Drugs · Drug Quality Assurance	551789