Premier Laser Warned
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Premier Laser Systems Inc. failed to properly record how it addressed complaints about its medical devices, the U.S. Food and Drug Administration said in an agency warning letter released Tuesday.
A spokesman for the Irvine-based manufacturer of medical lasers and other medical products said the FDA’s letter resulted from a series of misunderstandings and the agency has since sent the company another letter saying it’s satisfied with the company’s responses.
The FDA sends hundreds of warning letters to companies each year, but only a small fraction of them result in any significant agency action.
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