Roche Gets FDA Warning on Disetronic
Medical Systems Insulin Pump Plant
Issues raised by the inspection on three
separate occasions.
U.S. regulators have issued a warning letter
to Roche Diagnostics Corp. regarding what they
said were "serious problems" in the
manufacturing of insulin pumps at one of its plants
in Switzerland.
In a letter dated June 11, but posted on the FDA
Web site on Tuesday, the U.S. Food and Drug Administration
said it uncovered a variety of violations during
inspections of the Disetronic Medical Systems
plant in Burgdorf, Switzerland from Jan. 27 to
Feb. 5.
Disetronic, which was acquired by Swiss health
care company Roche Holding AG in early May, responded
to the issues raised by the inspection on three
separate occasions.
But the FDA, in its warning letter, called the
responses dated March 5, April 3 and May 6 "inadequate"
and said they failed to provide proper documentation
the problems had been corrected.
The FDA said the methods or controls used in the
manufacture, packing, storage or installation
of the devices did not conform with its requirements.
The FDA letter said the violations found in the
inspection, "may be symptomatic of serious
underlying problems in the Disetronic manufacturing
and quality assurance systems" and warned
that all Disetronic Medical Systems products may
be detained on entry into the United States "until
these violations are corrected."
Roche Diagnostics spokesman Joel Reuter said the
company was doing everything it could to bring
all Disetronic facilities up to standards. He
pointed out that the violations were uncovered
prior to Roche's acquisition of Disetronic.
"We have been working very hard over the
last several weeks to resolve these issues,"
said Reuter, adding that the company was working
closely with the FDA to make sure all of the agency's
concerns are addressed.
Roche Diagnostics is a division of Roche Holding
AG.
The U.S. regulators said they would likely need
to conduct a follow-up inspection to verify that
the company had corrected the problems.
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