Critical Issue Management

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Critical Issue Management for FDA 483 warning letters, recalls & safety alerts

  • Agency Representation & Negotiation
  • Recalls, Field Corrections & Safety Alerts
  • 483/Warning Letter/Consent Decree Resolution
  • Compliance Certification
  • Import Alert & Detention Removal Programs
  • Consent Decree Programs
  • HIPAA Subpoenas
  • Government Investigations
  • Major Product’s Liability Litigation
  • Integrity Inquiries
  • Import Alerts/Bans
  • Seizure
  • Injunctions
  • Administrative Detention
  • Civil Actions
  • Criminal Actions
  • Corporate or Multi-Facility Warning Letters
  • Monitoring of North American & European Union Regulatory Activities