United Therapeutics Corporation
Form 483 issued May 2, 2024 · Silver Spring, Maryland
- Inspection
- Apr 22 – May 2, 2024
- Investigators
- Annet R. Rajan· Janet A. Rajan· Mindy M. Chou
- Observations
- 3
- Pages
- 4
- FEI number
- 3003368324
In short: On May 2, 2024, FDA issued a Form 483 with 3 observations to United Therapeutics Corporation in Silver Spring, Maryland (FEI 3003368324) after an inspection that ran Apr 22 – May 2, 2024. The investigators were Annet R. Rajan, Janet A. Rajan and Mindy M. Chou. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmUnited Therapeutics Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at United Therapeutics Corporation?
FDA listed 3 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
Who inspected United Therapeutics Corporation?
Annet R. Rajan, Janet A. Rajan and Mindy M. Chou are named on this Form 483, for the inspection of Apr 22 – May 2, 2024. Each investigator has a profile showing what they cite most.
When was United Therapeutics Corporation inspected by FDA?
The inspection ran Apr 22 – May 2, 2024, and the Form 483 is dated May 2, 2024.
How do I get the full Form 483 for United Therapeutics Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.