The Food and Drug Administration recently sent a letter to Endo International, Inc., a company from Ireland who owns American Medical Systems, a medical tech firm from the United States. The warning letter stems from findings from the FDA during their inspection of the AMS plant located in Minnetonka. When the FDA inspected the facility in Minnesota, they discovered a number of issues that, according to the FDA, were related to “process validation, risk analysis, and corrective and preventative action procedures”.
What Is American Medical Systems?
AMS has been around since 1972, and in that time, they’ve been heavily involved in the creation and manufacture of various types of therapies and medical devices meant to help those who were suffering from pelvic disorders. The company has been in the news quite a bit lately, as they are also facing a substantial number of lawsuits regarding the vaginal mesh products they make. Women have been having trouble with the mesh, and the lawsuits concern the safety of the product.
One of the representatives of the company announced that this latest letter from the FDA does not actually have anything to do with the vaginal mesh products the company makes. They say it is unrelated, although they did not go into further details at that time.
Implementing Remedies for the Issues
In addition, the parent company Endo says American Medical Systems already knew about, and had identified, the problems that the FDA found in their inspection. They went on to say the regulators from the FDA requested that AMS try to move faster in the process of remedying those issues. American Medical Systems told the regulators what they were doing to take care of the problems, and they even claim to have met with the regulators to come up with a plan of correction.
Still, AMS received their warning from the FDA on April 14, 2014. The letter cites the same issues that they supposedly already knew about. The FDA says it sent the warning letter because the plan that the AMS was using to fix those problems was sufficient, but they found that many of the actions stated in the plan had not yet been implemented. They did not see enough progress on those changes, and therefore felt that issuing the letter, and conducting follow-up inspections, was warranted.
What Is AMS Doing Now?
According to an AMS filing with the SEC (Securities and Exchange Commission), they are now creating a response to the warning letter, while they are proceeding with their plan. They claim to be committed to making these changes within their company, and they feel they will make great strides in implementing all of those changes by the end of the year. The plan they have in place now should allow them to complete all of their changes and corrections by the end of 2015, if everything goes according to plan.
While they are fixing the issues, they will continue to make and ship products. Endo says that the impact from these changes will not affect their business and output on a large scale. The changes, for the most part, seem to be happening behind the scenes and should not affect day-to-day operations.
If they do not adhere to the warning from the FDA in a timely manner though, they do realize that they could be in for a variety of different problems with the law. Namely, they could face fines, civil penalties, seizure of products, and more. The FDA could also refuse to grant premarket approvals in the future for the company if they do not comply.