Med-Tech Firm Receives FDA Warning Over Minnetonka Plant

The FDA sent a warning letter to American Medical Systems, identifying issues related to “process validation, risk analysis, and corrective and preventive action procedures.”

Federal regulators recently sent a warning letter to the parent company of American Medical Systems (AMS) following an inspection of the company’s Minnetonka plant.

Ireland-based Endo International, Inc., which acquired Minnetonka-based AMS for $2.9 billion in 2011, disclosed in a regulatory filing last week that the U.S. Food and Drug Administration (FDA) inspected its Minnesota facility and subsequently issued a warning letter that found issues related to “process validation, risk analysis, and corrective and preventive action procedures.”

AMS was founded in 1972, and its medical devices and therapies help treat pelvic disorders. The company is reportedly currently facing thousands of lawsuits over the safety of its vaginal mesh products. A company spokesperson said Tuesday that the FDA letter “does not pertain to transvaginal mesh products,” although he declined to elaborate further.

Endo said that AMS had already identified the issues cited by the FDA, but regulators in February asked the company to accelerate the process of correcting them. In mid-March, AMS responded, explaining the actions it is taking to remedy the issues, and company officials then met with regulators and solidified a corrective plan, the company said.

On April 14, however, the company received an official warning letter from the FDA, which cites the same issues that regulators previously identified. The FDA said that AMS’ corrective plan appears adequate, but because many of the actions have yet to be completed, regulators will need to conduct a follow-up inspection.

AMS said that it is crafting a response to the FDA’s warning letter and continues to implement its corrective plan. “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,” the company said in a filing with the U.S. Securities and Exchange Commission.

Endo's regulatory filing said that AMS' Minnetonka facility will continue to manufacture and ship products throughout the process, and it expects “only limited related impact to its business at this time.”

The company acknowledged, however, that “failure to promptly correct the violations” addressed in the FDA’s warning letter or failure to comply with general regulatory requirements “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.”