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...
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