FDA lifts Staar Surgical warning letter

Staar Surgical (NSDQ:STAA) said today that the FDA lifted a 2014 warning letter issued over design and quality issues at a plant in California.

Inspections by the federal safety watchdog that year turned up 15 issues at the plant in Monrovia where the company makes its intraocular lenses.

The warning letter cited missing design files for the several models of the Visian implantable lenses, insufficient record-keeping of design changes and transfers, lack of risk analysis documentation and inadequate customer complaint management, among others.

“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,” president & CEO Caren Mason said in prepared remarks. “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.”

The post FDA lifts Staar Surgical warning letter appeared first on MassDevice.

from MassDevice https://ift.tt/2tmA1HF