Endo Hit With FDA Warning Over Vaginal Mesh Facility

Law360, New York (April 16, 2014, 5:47 PM EDT) -- Pharmaceutical company Endo International PLC has received a warning letter from the U.S. Food and Drug Administration concerning issues found after an inspection at its embattled vaginal mesh products subsidiary's Minnesota facility, the company said in a regulatory filing Wednesday.

Endo said the warning letter, dated April 10, follows up on issues previously identified by the FDA following an inspection of a facility in Minnetonka, Minn., run by its American Medical Systems Inc. subsidiary, according to the company's filing with the U.S. Securities and Exchange Commission.

The FDA had sent AMS a notice after the inspection with three issues that Endo...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!