Siemens Healthcare, a division of the German conglomerate Siemens ($SI), has gotten itself sideways with the FDA for manufacturing issues at its plant in Tarrytown, NY.
A warning letter sent to the company recently said that not only was it producing an assay test without getting premarket approval, but also that the company was not sufficiently investigating user complaints. The FDA also cited Siemens for not having an adequate system in place to ensure that the device was being made according to design specifications. The FDA says the company was not doing any reviews of design results and was lacking a process to approve any design changes of the assay before they were put in place.
A Siemens spokesman says that the company "has implemented and continues to implement a series of corrective and preventive actions to fully address the issues identified by the FDA.
"We are working with the FDA and are committed to resolving these issues in the best interest of our customers, doctors and the patients they serve," he said. "This matter has the highest priority within the organization."
This is not the only regulatory issue the company faces in the U.S. right now. It recently disclosed that its diagnostics arm also faces an investigation from the U.S. Attorney's Office in the Eastern District of New York. Siemens disclosed that the office served a subpoena to the company in February regarding "a diagnostics process," it said in its second-quarter financial filings.
- read the FDA warning letter