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STAAR works to correct observed deficits in good manufacturing practices
The FDA may withhold approval of new products such as the toric ICL or take additional regulatory or legal action against STAAR Surgical, unless and until STAAR corrects outstanding issues to the FDA’s satisfaction, according to a form the company issued to the Securities and Exchange Commission.
On Feb. 4, after inspections of the company’s Monrovia, Calif., facility concluded, the FDA issued a Form 483 outlining 10 observations that center mainly on “the need for adherence to and improved procedures, processes and documentation relating to design change, design transfer into specifications and production, verification and validation associated with device design and production, improvement in good documentation practices, and broader environmental monitoring,” according to the STAAR filing.
The FDA had previously issued a warning letter on May 21, 2014, regarding compliance with current good manufacturing practices at the Monrovia facility.
“STAAR is currently drafting a response to the FDA’s observations and is concurrently continuing to develop and implement its corrective action plans relating to the 2014 warning letter and the Form 483,” the filing said. “STAAR takes the matters identified by FDA seriously and will continue to work diligently to address the observations identified in the Form 483 and 2014 warning letter.”
The FDA’s Ophthalmic Devices Panel recommended approval of STAAR’s Visian toric ICL to treat myopia and astigmatism in March 2014. The FDA has not granted final approval of the device.