This week’s offenders are charged with smuggling and unlawful use of silicone, injecting it straight into the buttocks.
Penetrating the skin introduces a different set of unavoidable safety and efficacy questions.
Adulteration, misbranding and design validation cause a problem for one company.
There’s nothing sweet about what happened to the owner and operator of Candy Color Lenses.
Inquiries from FDA cannot be ignored. You must respond, especially if the agency contacts your establishment more than once.
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”