Endo Health Solutions Inc. Unit Receives FDA Warning Letter Tied To Form 483 Notice
Published: Apr 17, 2014
As previously reported in Endo Health Solutions Inc.’s Form 10-K filed with the SEC on March 3, 2014, in February 2014, the United States Food and Drug Administration (the “FDA”) conducted an inspection of the Minnetonka, Minnesota facility of American Medical Systems, Inc. (“AMS”), a subsidiary of Endo International plc (Nasdaq: ENDP). Following such inspection, the FDA issued three observations on a Form 483 Notice of Inspectional Observations dated February 24, 2014 (the “Form 483 Notice”). These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015.
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