FDA Warns Anika About 'Adulterated' Devices

Law360, New York (July 22, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has warned Anika Therapeutics Inc. that it must take corrective actions to remedy a slew of manufacturing violations at the medical device maker’s Woburn, Mass., facility, according to a letter made public Monday by the agency.

The letter, dated July 2 but posted on the FDA’s Web site Monday, cites a laundry list of problems identified by agency inspectors in March related to Anika’s Amvisc, Amvisc Plus, Staarvisc II, Shellgel and Orthovisc devices.

According to the FDA, the inspection revealed...
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