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Medical Devices / Inspections and Audits

Sybaritic Flagged for Failing to Follow Consent Decree

July 17, 2018
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The FDA cited device manufacturer Sybaritic of Bloomington, Minnesota following a Feb. 22 to March 7 inspection for failing to comply with the terms of a consent decree.

The firm had signed a consent decree of permanent injunction in January 2010 and the agency inspection found that it continued to market its products with unapproved health claims even though the decree specifically prohibited it from designing, manufacturing, processing, packing, repacking, holding, distributing, importing or exporting any device.

The 483 said the firm failed to comply with the consent decree because it did not provide a copy of the consent decree to new associates, including suppliers.

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