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ENFORCEMENT ACTIONS

When a company or individual is subject to an enforcement action by a regulatory agency or prosecutor knowing what to do and how to respond is paramount to achieving the best outcome.

JENLO Compliance has extensive experience in responding to a wide range of enforcement actions and establishing tangible and actionable project plans to resolve issues including:

  • Warning Letters

  • FDA 483 responses and remediation

  • Import Detentions

  • Consent Decrees

  • Seizures

  • Untitled Letters

  • Debarment Proceedings

  • Exclusion Proceedings

  • Administrative subpoenas

  • Grand Jury subpoenas

  • Search Warrants

  • MOH inquiries

Whether it is the FDA, DEA, OIG, FTC, CMS, HHS, State Boards of Pharmacy or States Attorneys General, we can guide you through what to do and not to do to achieve a successful outcome.