The FDA has cited Siemens Healthcare's diagnostics arm for marketing a diagnostic test system used to assess everything from allergies to anemia and hepatitis without formal approval. Regulators also slammed the company for various quality system violations regarding the product's manufacturing.
All of this stems from regulators' inspection of the company's Tarrytown, NY manufacturing facility between Oct. 24 and Dec. 29, 2011, relating to the production of the company's AD VIA Centaur iPTH immunoassay. The FDA issued its formal warning letter on May 29.
Siemens Healthcare, a division of the German conglomerate Siemens ($SI) was found to not have premarket approval or an investigational device exemption for the test. FDA inspectors also said the test is misbranded because the company "did not notify the agency of its intent to introduce the device into commercial distribution."
Separately, the FDA cited Siemens for not have an adequate system in place to ensure the device was being made according to design specifications. The FDA also singled out the company for not doing any reviews of design results and for lacking a process to approve any design changes of the assay before they were put in place. Additionally, Siemens hasn't sufficiently reviewed product complaints to determine if it needed to formally investigate, according to the FDA's letter.
A Siemens spokesman told FierceMedicalDevices 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."
Siemens has 15 days to respond in writing from the date it received the warning letter and explain steps it has taken to address any noted violations and also how to prevent them in the future.
- read the warning letter here