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March 18, 2013
09:11 EDTNUVANuVasive says received FDA warning letter related to San Diego facility
On March 13, NuVasive received a warning letter dated March 12 from the FDA related to an inspection of the company’s San Diego, California facility that occurred from October 29, 2012 through November 2, 2012. The inspection did not result in any 483 observations and the warning letter does not cite any quality system concerns.The FDA letter identifies specific labeling claims related to the company’s ILIF procedure, indicating that one of the indications noted is not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s. The letter only relates to this promotional claim and the company does not anticipate a disruption in the distribution of these products. The company takes this matter seriously and has already begun to respond to the FDA’s requests. The company is giving the matter the highest priority in order to fully address the FDA’s concerns to our mutual satisfaction. As this is an administrative process to address the warning letter, the company believes the FDA’s concerns can be resolved without an impact on the company’s financial results or operations. Comments taken from an 8-K filing.
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