FDA warns Surgisil for unapproved facial implant marketing

FDA issued a Warning Letter to a medical device company that manufactures a facial implant device due to a number of deficiencies found during a 2018 inspection. Based on the inspection, FDA found that the company’s marketing materials for the device, including instructional videos and.

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Eleven Biotherapeutics, Inc. (the “Company”), a Delaware corporation formed on February 25, 2008, is a biologics oncology company focused on designing, engineering and developing targeted protein.

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In a new US Food and drug administration (fda) warning letter, Plano, TX-based Surgisil was urged to come into compliance with the marketing of its Perma Facial Implant over an unapproved intended use. fda conducted an inspection of Surgisil’s operations, including its website , last September and determined the firm had been marketing the.

the onus on the FDA to assess compliance by sending investigators According to inspect clinics. Based on such inspections, the autologous FDA must determine whether regulatory action is justied. the While the FDA has issued warning letters to several crystalloids, businesses marketing adipose-derived stem cell interventions, provided

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Based on such inspections, the FDA must determine whether regulatory action is justified. While the FDA has issued warning letters to several businesses marketing adipose-derived stem cell interventions, most US stem cell clinics operate for years without attracting attention from federal or state regulators.