FDA warns Anika over device manufacturing

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FDA warns Anika over device manufacturing

July 25th, 2008 joshua

The Food and Drug Administration has warned Anika Therapeutics about its manufacturing process.

Regulators sent the Massachusetts-based manufacturer of Amvisc, Amvisc Plus, Staarvisc II, Shellgel and Orthovisc a warning letter about its practices on July 2. The company also makes the prescription veterinary medicine, Hyvisc.

It said the devices the company is making are “adulterated” because “the methods used in, or the facilities or controls used for, their manufacture, packing storage or installation are not in conformity” with federal standards, the FDA wrote.

Anika’s production of its veterinary medicine also lacked the federal standard, too, regulators warned.

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