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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.

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.. FDA found that the company’s.

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934: None. Securities registered pursuant to Section 12(g) of the Act: Indicate by check mark whether the registrant.

Surgisil Warned for Unapproved Marketing of facial implant plano, Texas devicemaker Surgisil is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks.

Securities registered pursuant to Section 12(g) of the Exchange Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes .

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.

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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.

FDA Warns Pregnant Women Against Use of Topamax. The Food and Drug Administration has issued a warning against the use of anticonvulsant drug Topamax during pregnancy, saying that infants born to women using the drug are 20 percent more at risk of developing cleft lips and such other deformities.