Endo Int'l (ENDP) Unit Receives FDA Warning Letter Tied to Form 483 Notice

Discussion in 'American Medical Systems' started by Anonymous, Apr 16, 2014 at 9:30 AM.

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  1. Anonymous

    Anonymous Guest

    Endo Int'l (ENDP) Unit Receives FDA Warning Letter Tied to Form 483 Notice
    8:25 AM ET, 04/16/2014 - Street Insider

    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.
    AMS provided the FDA an accelerated action plan to address its internal findings in a letter dated February 24, 2014. Subsequently, in a Form 483 response letter dated March 10, 2014, AMS provided the FDA with a comprehensive response to the Form 483 Notice to further expand on the action plan, explain the corrective actions being undertaken by AMS and reaffirm its commitment to achieving full sustainable compliance with applicable laws and regulations. On March 20, 2014 AMS management met with the FDA, expanded further on the action plan and agreed on the approach.
    On April 14, 2014, AMS received a Warning Letter from the FDA, dated April 10, 2014. The Warning Letter relates to the same matters as identified in the Form 483 Notice. Specifically, the Warning Letter discusses observations related to process validation, risk analysis and corrective and preventive action procedures.
    The letter states that the corrective actions which AMS reviewed with the FDA on March 20, 2014 appear to be adequate, but it goes on to state that many of the actions have not yet been completed and will need to be validated in a follow-up inspection. AMS has 15 days to respond to the Warning Letter.
    AMS is currently drafting a response to the April 10, 2014 Warning Letter, in addition to continuing to implement its corrective action plan as agreed with the FDA. AMS is committed and expects to continue to make significant progress during the remainder of 2014, with completion of the proposed corrective actions expected to occur by the end of 2015.
    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.
    However, failure to promptly correct the violations addressed in the April 10, 2014 Warning Letter or to comply with the U.S. medical device regulatory requirements in general could result in, among other things, fines, injunctions, consent decrees, civil money penalties, repairs, replacements, refunds, recalls or seizures of products, total or partial suspension of production, the FDA s refusal to grant future premarket approvals, withdrawals or suspensions of current product applications and criminal prosecution.
     

  2. Anonymous

    Anonymous Guest

    Wow!
     
  3. Anonymous

    Anonymous Guest

    Who is surprised at this? Camille has hired a temp o write, in english the the Form 483 response.
     
  4. Anonymous

    Anonymous Guest

    Your English could use some help.
     
  5. Anonymous

    Anonymous Guest

    It be my second language.
     
  6. Anonymous

    Anonymous Guest

    This is no big deal. This goes all the way back to the days Marty Emersen was the CEO. It has to do with re-validating some processes and stuff.

    Endo International says AMS unit received FDA warning letter
    In a regulatory filing, Endo International disclosed that as previously reported in Endo Health Solutions's Form 10-K filed with the SEC on March 3, in February 2014, the United States FDA conducted an inspection of the Minnetonka, Minnesota facility of American Medical Systems, AMS, a subsidiary of Endo International. Following such inspection, the FDA issued three observations on a Form 483 Notice of Inspectional Observations dated February 24. These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015. On April 14, AMS received a Warning Letter from the FDA, dated April 10. The Warning Letter relates to the same matters as identified in the Form 483 Notice. Specifically, the Warning Letter discusses observations related to process validation, risk analysis and corrective and preventive action procedures. The letter states that the corrective actions which AMS reviewed with the FDA on March 20, 2014 appear to be adequate, but it goes on to state that many of the actions have not yet been completed and will need to be validated in a follow-up inspection. AMS has 15 days to respond to the Warning Letter. 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.
     
  7. Anonymous

    Anonymous Guest

    FDA warns Endo Health on AMS pelvic mesh plant

    April 17, 2014 by Brad Perriello

    The FDA sends a warning letter to Endo Health's American Medical Systems subsidiary over procedural violations at the Minnetonka, Minn., plant that makes pelvic mesh products.

    Endo Health Solutions (NSDQ:ENDP) said the FDA warned it about procedural violations at a Minnesota plant run by its American Medical Systems subsidiary that makes pelvic mesh products.

    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.