FDA Chides Device Maker Nidek Over Quality Controls

Law360, New York (October 8, 2013, 3:25 PM EDT) -- Nidek Co. Ltd., a Japan-based manufacturer of laser eye surgery equipment, recently botched its quality controls in numerous ways that undermined the soundness of its manufacturing operations, according to a warning letter released Tuesday by the U.S. Food and Drug Administration.

The Sept. 24 letter came on the heels of a so-called Form 483 that the FDA issued after uncovering compliance problems during inspections in May. A half-dozen violations are described in the correspondence, including the alleged failure of company management to evaluate the effectiveness of...
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