FDA Warns Anika Therapeutics on Problems at Manufacturing Plant

U.S. regulators have warned Anika Therapeutics Inc. about manufacturing problems uncovered during a March inspection of a plant in Woburn, Massachusetts, a recently released letter said.

The company produces the Amvisc, Amvisc Plus, Staarvisc II, Shellgel and Orthovisc medical devices at the facility, as well as the Hyvisc prescription animal drug, the July 2 letter from the Food and Drug Administration said.

The devices 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 manufacturing standards, the FDA said.

Inspectors also found the manufacture of Hyvisc did not meet manufacturing standards, the letter said.

Officials at the company could not immediately be reached for comment.

The FDA sends dozens of warning letters per year. Most issues are resolved without further action, but the agency can impose fines or other penalties.

SOURCE: Reuters