Inspections, Compliance, Enforcement, and Criminal Investigations


This chapter provides policy, definitions, responsibilities, and procedures for agency components to initiate, review, classify, publish, audit and terminate recall actions. It implements 21 CFR Part 7 Subpart C – Recalls (Including Product Corrections) – Guidelines on Policy, Procedures, and Industry Responsibilities. (See also Investigations Operations Manual, Chapter 8, Recall Activities). It also discusses various FDA mandated recalls and includes a reference to the procedures for each of these authorities, including recalls of Medical Devices, Radiation Emitting Electronic Products, Biological Products, Human Tissue Intended for Transplantation, Infant Formula, Tobacco Products, and mandatory recall of Food Products.1

1 FDA does not ordinarily classify or audit interstate milk shippers (IMS) product recalls where such actions have been, or are being, handled expeditiously and appropriately by the state(s). The FDA district office in which the recalling firm is located must be ensured that all states involved in an IMS plant's recall are participating in ensuring removal of the product from commerce and that, when appropriate, states issue warnings to protect the public health. In the event that FDA determines that the states are unable to effect the recall actions necessary, the agency will classify, publish, and audit the recall, including issuance of a public warning when indicated.

Page Last Updated: 06/19/2015
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