Staar Surgical (NSDQ:STAA) said yesterday that it received another warning from the FDA over documentation problems at its plant in Monrovia, Calif.
The federal safety watchdog inspected the Monrovia facility from Nov. 14 last year through Feb. 4, finding 10 problems with the way Staar documents product changes and other issues, the company said in a regulatory filing.
The 10 problems noted by FDA inspectors “focus primarily 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,” Staar said.
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