Enforcement Mechanisms Available to the FDA

by | 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.

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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