The warning stems from an FDA inspection of the Minnetonka, Minn., plant in February that resulted in a "Form 483" warning from the watchdog agency, Endo Health said in a regulatory filing.
"These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015," according to the filing.
AMS accelerated and expanded its corrective action plan following the February inspection and receipt of the Form 483 warning, the company said. AMS management met in person with FDA representatives last month, according to the filing, when they "expanded further on the action plan and agreed on the approach."
The agency’s April 10 warning letter said "the corrective actions which AMS reviewed with the FDA on March 20, 2014, appear to be adequate," according to the filing, which noted that the FDA will require a follow-up inspection to validate the changes made at the plant.
"AMS expects only limited related impact to its business at this time. The Minnetonka, Minnesota facility will continue to manufacture and ship products while AMS works with the FDA," according to the filing.
Endo and a raft of other pelvic mesh makers are facing thousands of product liability lawsuits in state and federal court. Hundreds of cases involving Boston Scientific (NYSE:BSX), Johnson & Johnson (NYSE:JNJ), Secant Medical, C.R. Bard(NYSE:BCR), Endo Health Solutions (NSDQ:ENDP), Cook Medical and Coloplast (CPH:COLO B) have been consolidated into multi-district litigation under Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia.
In February, more cases were consolidated by Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas. Earlier this week plaintiffs whose cases were removed to the U.S. District Court for Eastern Pennsylvania filed motions to have their suits moved to the court in Philly as well.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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