Issue 165 Item 14 Roche Gets FDA Warning on Disetronic Medical Systems Insulin P

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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