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| Pinnacle Destination guiding sheath--Courtesy of Terumo |
Tokyo's Terumo has been hit with a dreaded FDA warning letter. The agency last week said the company's guiding sheaths for renal, carotid and peripheral use are adulterated under the Federal Food, Drug, and Cosmetic Act. It cited numerous manufacturing flaws that violate the Quality System regulation in Terumo's Elkhart, MD facility.
Following the FDA's October inspection, Terumo responded to all 7 violations listed in the letter, but the agency determined that the firm's answers were inadequate.
The violations detailed include failure to maintain and establish procedures to control or dispose of nonconforming products, failure to maintain and establish procedures for verifying and validating device design, and failure to ensure that that a device conforms to its specifications.
And the FDA issued its standard warning letter, well, warning: "Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts."
In addition, PMA applications for devices to which the violations are related will not be considered until the warning letter covering the Maryland facility is related.
Terumo has been requested to respond with planned corrections within 15 days of receiving the letter.
Terumo's Pinnacle Destination peripheral guiding sheath was originally cleared in 2005, according to the FDA database. It's indicated for the introduction of diagnostic and interventional devices into the human vasculature.
- read the warning letter (PDF)