The FDA last week sent a warning letter to Terumo Corp. (TYO:4543) over issues with the manufacturing and quality control of its Destination Guiding vascular sheaths.
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.
