FDA warns OsteoSymbionics over manufacturing violations

12/12/2010 | MedCityNews.com

The FDA has issued a warning letter to cranial implant developer OsteoSymbionics alleging manufacturing violations, including failure to set up processes guaranteeing that standards for product design are met. "Most of the issues have been addressed and corrected, and those that haven't will be taken care of in the first quarter," said the company's CEO, Cynthia Brogan.

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