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U.S. shipments on hold pending FDA actionThe ultrasound group of Siemens Medical Systems rolled out thered carpet last month at its new headquarters in Issaquah, WA.Siemens hopes the move will open a new chapter for the division,which is still
The ultrasound group of Siemens Medical Systems rolled out thered carpet last month at its new headquarters in Issaquah, WA.Siemens hopes the move will open a new chapter for the division,which is still operating under the terms of a consent decree withthe Food and Drug Administration that prevents Siemens from shippingultrasound scanners in the U.S.
Siemens made the move to a new facility to consolidate theultrasound group's operations, which were spread across severallocations in Issaquah. Siemens inherited the facilities when itbought Quantum in 1990 (SCAN 4/11/90). Siemens moved its San Ramon,CA, ultrasound operation to Issaquah in 1992 to centralize thebusiness (SCAN 6/3/92).
The ultrasound group was one of three Siemens business unitsthat ran afoul of the FDA earlier this year over good manufacturingpractices in the vendor's complaint-handling process (SCAN 3/2/94).As part of a consent decree with the agency, Siemens agreed tosuspend U.S. shipments of products manufactured at the units untilthe problems could be rectified.
For the ultrasound group, the consent decree applied only tothe older facility in Issaquah, and Siemens initially believedit could begin shipments again once the new headquarters opened.Since then, however, the vendor has decided to avoid taking anychances and will await an FDA inspection of the facility beforeresuming domestic shipments, according to Lothar Koob, group vicepresident of the ultrasound division.
"We want to make sure that there is no compliance issuewith the new factory," Koob said. "We made a huge effortto make sure that all the processes that were validated in theold facility were not affected by the move."
The new complex should bring a number of benefits to the ultrasoundgroup, according to Koob. Communication between different unitswill be improved by having the entire group under one roof. Inaddition, the new facility has been adapted to Siemens' specificationsand is designed to grow with the division, while at the old headquartersSiemens employees had to be squeezed into whatever space was available.
Siemens is ready to begin shipping in the U.S. once the FDAcan complete an inspection, which the vendor hopes will occursome time in July. Siemens is already shipping ultrasound systemsoverseas, Koob said.