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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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7-1 - PURPOSE

 7-1 - PURPOSE

  7-1 - PURPOSE

This chapter provides policy, definitions, responsibilities, and procedures for agency units 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.)

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