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RECENT UPDATES

  • Mar 12, 2026
    Department of Justice Corporate Enforcement and Voluntary Self-Disclosure Policy (March 10, 2026) (department-wide corporate enforcement policy for criminal matters added).
  • Mar 9, 2026
    Responding to FDA Form 483 Observations at the Conclusion of a Drug cGMP Inspection (Draft Guidance — March 2026) (draft guidance added).
  • Feb 19, 2026
    ¶915 — FDA's Permissive Debarment Authority for Drug Importers (Debarment Status of Individuals (Drug Importation) table updated).
  • Feb 17, 2026
    ¶667 — Cosmetics (section on FDA-mandated cosmetics recalls added).
  • Feb 6, 2026
    ¶745 — Debarment Status Chart (Debarment Status of Individuals chart updated).
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    FDA Enforcement Manual, March 2026
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