FDA warns Surgisil for unapproved facial implant marketing

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The FDA has issued a warning letter to Evenflo, citing it for failing to investigate approximately half of the complaints reviewed by FDA inspectors. Device Claims On Website Attract Warning Letter The FDA has issued a warning letter to Netproductstore, requesting that the distributor stop marketing the Rhythm Touch Q 2-Way for unapproved uses.

Texas Firm Draws FDA Warning Over Adulterated Device . Texas Firm Draws FDA Warning Over Adulterated Device . raps.org 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.

Dermal Fillers News Search. FDA Warns Of Side Effects, Unapproved Use Of Expressions As Dermal Filler. 09 August 2014. The Food and Drug Administration (FDA) is warning doctors that Expression brand injectable product made by Enhancement Medical should not be used as a dermal filler because the product has not been approved for this use and.

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 · Warning letters have declined, the FDA said, because the agency is using a new approach that involves fewer warnings but more inspections to oversee companies that violate its rules. Last week, the FDA announced a new goal to be “consistently first” among the world’s regulatory agencies to identify and address medical device safety issues.

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