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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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7-2 - BACKGROUND

7-2 - BACKGROUND

  7-2 - BACKGROUND

Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed.

Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA.

All agency components are expected to follow the requirements of this chapter. Although this chapter primarily implements 21 CFR Part 7 Subpart C, some deviation from the policy, definitions, responsibilities, and procedures under 21 CFR Part 7 Subpart C may occur in the initiation of mandatory device recalls ordered under section 518(e) of the Federal Food, Drug, and Cosmetic Act (the Act), corrective action programs (recalls) involving radiation emitting medical devices and electronic products, infant formula recalls, tobacco products, human tissue recalls, and mandatory recall of food. These deviations in policy, definitions, responsibilities, and procedures are noted throughout this chapter.

Guidelines delineating the responsibilities of industry in conducting recalls are in 21 CFR 7.40-7.59. An additional document titled “Product Recalls, Including Removals and Corrections - Industry Guidance” is available on the Internet at the FDA web site. It is designed for all FDA regulated industry and provides guidance both in the conduct of recalls and in the information needed by FDA to classify, monitor, and assess the effectiveness of a recall.