Enforcement Mechanisms Available to the FDA

by Nikita Angane | Apr 16, 2021 | Uncategorized

The mission of the Food and Drug Administration is to protect public health by ensuring compliance of products and goods with the Food, Drug, and Cosmetic Act. In order to do this, the FDA, through its centers, conducts post-market enforcement activities which include the removal of nonconforming products from the market and other actions to correct the violations. The type of enforcement activity is commensurate with the violations and may include a letter notifying the firm and requesting a correction to the criminal prosecution of the responsible firm or individual(s).

This whitepaper discusses the types of enforcement tools available to the FDA and what it means to the firm or the individual(s) involved.

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Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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