Enforcement Defense

Facing an enforcement action can be a daunting and stressful experience, with the potential to significantly impact your business operations and reputation. At Asebey Life Science Law, we understand the urgency and pressure that come with these situations. Our team is committed to providing swift, effective, and strategic legal support to help you navigate enforcement challenges and protect your business.

Our enforcement defense practice offers comprehensive legal assistance in responding to Warning Letters and Form 483 observations from the FDA. We specialize in the removal of companies from FDA Import Alerts for food, dietary supplements, medical devices, cosmetics and drugs, as well as providing defense against Prop 65 claims for food, dietary supplements, and cosmetics. Additionally, we manage FDA and state facility inspections, ensuring that our clients are well-prepared and compliant.

We also offer crisis management services for recalls involving food, cosmetics, medical devices, dietary supplements, and drugs. Our expertise extends to FDA inspection preparation, CBP import detentions and seizures defense, and petitions for the mitigation of liquidated damages to CBP. At Asebey Life Science Law, we are dedicated to defending your business with legal acumen and a strategic approach, ensuring the best possible outcomes during enforcement actions.

Our services encompass:

  • Warning Letters and 483s responses to FDA
  • Removal from FDA Import Alert (food, drugs, dietary supplements, drugs)
  • Prop 65 Defense (food, dietary supplements, and cosmetics)
  • FDA and State Facility Inspection Management
  • Recalls and Crisis Management (food, cosmetics, medical devices, dietary supplements, and drugs)
  • FDA Import Alert Removal
  • FDA Inspection preparation
  • CBP Import Detentions & Seizures Defense
  • Petitions for Mitigation of Liquidated Damages to CBP

Tell us more about your regulatory needs so we can help you succeed.

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