Staar Surgical strengthens RA
This article was originally published in The Gray Sheet
Executive Summary
Eye product company hires James Farnworth as VP-quality, regulatory & clinical affairs Oct. 12. Farnworth will help resolve QSR compliance issues and trial monitoring violations cited at Staar's Monrovia, Calif. plant (1"The Gray Sheet" Oct. 4, 2004, In Brief). He formerly was director of regulatory affairs & quality assurance at Volcano Therapeutics. Quintiles still will be retained by Staar, whose Visian ICL intraocular lens awaits PMA approval...
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Staar Surgical Visian ICL
Implantable contact lens PMA approval for myopia likely will be delayed beyond the Oct. 22 American Academy of Ophthalmologists meeting, the firm says, following Sept. 23 receipt of 36 "FDA 483" observations stemming from a re-inspection of its Monrovia, Calif. manufacturing facility. An initial inspection led to a December 2003 warning letter and subsequent Staar corrections. Current observations include quality system and complaint handling issues. Staar is preparing a written response and will undertake further corrective action (1"The Gray Sheet" Sept. 20, 2004, p. 3)...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.