The agency hit the company for marketing the product as something other than a device, outside the FDA’s guidelines.
The FDA said the company had responded to its original concerns after an investigator inspected the facility, and picked out 3 deficiencies specific to Sorin and the Stockert Heater Cooler’s manufacturing.
The federal watchdog knocked Sorin on failures to maintain identification, documentation and validation procedures, process validation and reporting procedures.
The FDA noted 2 specific issues with design changes from Sorin that were deficient, including changes related to reducing biofilm and bacterial growth, with a number of specifically noted problems that the company’s response letter did not cover.
Efficacy tests and manufacturer monitoring were also noted as deficient, again noting the lack of tracking for bacterial growth with the device.
The last note the FDA touched on concerned its medical device reporting procedures, including lack of establishing systems for identifying, communicating and evaluating events related to reporting, according to the warning letter.
The agency again noted the lack of premarket approval for the device, and said it was “taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected.”
The FDA gave the company 15 days to respond to the letter, which was issued December 29.