FDA Lifts Shipping Restrictions On Terumo’s Michigan Plant
Terumo Corp. (TYO:4543) said today it received a notice from the FDA lifting all shipping restrictions at its Ann Arbor, Mich. facility that were imposed in 2011 as part of the company’s consent decree.
The step is the 2nd and final phase of the company’s work plan to remediate products manufactured at the facility to comply with the FDA’s requirements, Terumo said.
“This means we have demonstrated to the FDA that we have the Quality System and infrastructure needed to manufacture life-sustaining devices in full compliance with the FDA regulation.
The step is the 2nd and final phase of the company’s work plan to remediate products manufactured at the facility to comply with the FDA’s requirements, Terumo said.
“This means we have demonstrated to the FDA that we have the Quality System and infrastructure needed to manufacture life-sustaining devices in full compliance with the FDA regulation.