The agency warned the company over issues with the manufacturing, packing, storage and installation at the facility that produces its Destination sheaths, referencing failures around design and conformity.
The letter came based on an inspection in October last year, which the agency said Terumo had already responded to several times. However, the FDA said it still found inadequacies in the company’s responses.
The FDA referenced 7 inadequacies from Terumo in total, all centering around overseeing conformity in products, establishing design verification and validation and monitoring during manufacturing.
In referencing a failure to establish and maintain procedures to control nonconforming product, the FDA said it reviewed a response from Terumo and found it inadequate. The agency pinged the company for not providing evidence of the “Implementation and effectiveness of all identified corrective actions.”
The federal watchdog referenced a failure to oversee and manage nonconforming products, saying that while Terumo responded to the issue, it had not yet identified how nonconforming materials will be handled.
The agency said Terumo had failed to establish design verification and validation procedures, saying that in its response it had not provided evidence of the implementation it suggested.
Terumo was given 15 days to respond to the inadequacies it found, saying “the adequacy of your firm’s response cannot be determined at this time,” according to the warning letter.