critical issue management

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

What is Critical Issue Management?

Bioteknica can help resolve issues arising from FDA management mishaps including warnings, recalls, and safety alerts that may be issued by the federal agency by preventing these mistakes from happening.

We pride ourselves in following strict guidelines, ensuring all protocols, and noting every detail so that we are 100% compliant.

If you do find yourself now dealing with compliance management issues, we help clients like you by providing support in any of the above areas to ensure that you have the right risk assessments,  management plan, and certifications needed in place and are able to resolve them.