Ophthalmic products maker Staar Surgical Co. said Thursday it believed the U.S. Food and Drug Administration was unlikely to pursue enforcement action against the company based on a Wednesday inspection of its main manufacturing plant.
Representatives of the FDA's Los Angeles district office completed an inspection of the company's primary facility in Monrovia that began August 29. The tour included an inspection in connection with the company's effort to win approval for its Visian implantable contact lens, which Staar believes will be a competitor of laser surgery.
The inspectors issued three "inspectional observations," noting one already had been corrected, Staar said in a regulatory filing. The company promised to correct the remaining two issues.
Staar received a letter from regulators in July stating the Visian ICL could be approved pending the U.S. plant inspection, and review of the findings by the FDA's Center for Devices and Radiological Health. The lens which already is approved for sale in 41 countries, is manufactured at a Swiss facility. But regulators can block a company's launch of a new product in the U.S. if they have concerns about any of its facilities.
During a routine inspection in preparation for the final stages of the Visian approval in 2003, the FDA found several problems the company's manufacturing process, quality control, and questioned whether the proper procedures were followed in reporting adverse events and other problems.
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