06.20.18

Staar Surgical Announces Resolution of FDA Warning Letter

Source: Staar Surgical

STAAR Surgical announced that it received a close-out letter from the FDA on June 19, 2018 lifting a Warning Letter dated May 21, 2014.

“The lifting of the Warning Letter is the result of a comprehensive remediation program that not only addressed the issues raised by the FDA in the 2014 Warning Letter, but included the assessment, remediation and upgrade of all aspects of Staar’s quality systems to assure compliance with Quality System Regulations (QSR),” Caren Mason, President and CEO, said in a company news release. “We have steadfastly initiated and promoted a Culture of Quality which emphasizes prevention and accountability throughout the organization. We are committed to continuing and strengthening this companywide emphasis on excellence.”

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