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Staar warning letter progress

This article was originally published in The Gray Sheet

Executive Summary

Staar Surgical is preparing for facility inspections following FDA's recent pronouncement that the firm's warning letter corrective action plan is "adequate," the company says. The Dec. 22 warning letter stemmed from quality system regulation and device reporting violations discovered during a pre-approval inspection related to Staar's Collamer implantable contact lens (1"The Gray Sheet" Jan. 12, 2004, p. 7). Staar will provide an update on the expected re-inspection timeframe by the end of April. The firm's stock rose 21% March 31 on disclosure of the development...

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