Recalls

Whether a recall is voluntary or requested by a state regulator or FDA, compounders and pharmaceutical manufacturers must have written procedures to initiate, trace and report drug recalls to FDA and state agencies.

 

Our consultants have experience in handling and reporting drug recalls in a simplified and timely manner to mitigate patient harm and regulatory backlash.

  • We partner with your leadership, legal, and communications teams to develop a comprehensive strategy to get you back on the market.

  • We excel at initiating the recall, investigating the event, and creating an action plan to prevent similar future events.

  • We can also conduct mock recalls to assess your readiness to execute an actual recall or perform a gap analysis as a proactive recall prevention strategy.

Your recall must be initiated and reported quickly and accurately, don’t wait too long to contact the right team to get you through this unfortunate situation.

 

Our Approach

  1. Event Discovery

  2. Recall Initiation and Execution

  3. Investigation Support

  4. CAPA Plan

  5. Remediation Implementation