Brian Buntz

March 25, 2016

2 Min Read
Terumo Gets FDA Warning Letter

Terumo (Tokyo) was hit with a FDA warning letter relating to the manufacture of its renal, carotid and peripheral use are adulterated under the Federal Food, Drug, and Cosmetic Act.

Qmed Staff

The FDA has sent a warning letter to Terumo Corp., warning the company about manufacturing and quality control deficiencies related to its Destination line of guiding vascular sheaths.

The problems, which were outlined in the publicly available letter, specifically related to noncompliance of the company's manufacturing, packing, storage, and installation at a facility that produces the Destination sheaths with regulations described in Title 21, Code of Federal Regulations (CFR), Part 820.

The warning letter stemmed from an FDA inspection of the company's facilities on October 19, 2015.

While the company had responded several times to the FDA, the agency concluded that the firm's response was inadequate and stated that the company had not demonstrated the effectiveness of all of the identified corrective actions outlined in earlier communications.

The warning letter further questioned the company's quality control measures used to ensure the quality of renal sheaths on 11/19/2014 and 11/20/2014 and Terumo's response to previous 483 document. "Though your firm's response describes several practices used for ensuring that the solution bottles used in production are acceptable, your firm has not provided information about how nonconforming materials, including [nonconforming bottles] will be handled," the letter concludes. 

The letter further questioned the company's controls for identifying and segregating nonconforming materials and its ability to verify device design according to 21 CFR 820.30(f) and questioned its compliance with 21 CFR 820.75(a).

If Terumo does not satisfy the demands outlined in the letter, the FDA reserves the right to seize products, impose an injunction, fine the company, and possibly exclude the products from coverage from federal agencies. Furthermore, FDA reserves the right to withhold approval for similar Class III devices until the violations have been addressed. 

Terumo was given 15 days to respond to the letter.

The company's Pinnacle Destination peripheral guiding sheath was originally approved by FDA in 2005.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016. 

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