FDA 483 Action Planning & Remediation

SITUATION
An early stage device company received a 483 with multiple observations after a long two-week BIMO inspection and were in need of strategic support to address findings in a short period of time and develop an action plan for remediation.

SOLUTION

  • Halloran quickly assembled a cross-functional team to investigate the core issues at hand, perform a root cause analysis, and identify solutions targeted at both immediate corrections and longer term preventative actions.
  • A detailed action plan was developed with specific activities, owners, and timelines for completion of deliverables to ensure immediate corrections were completed and key objective evidence was available on time for the initial response. 
  • Halloran provided interim strategic clinical leadership in support of drafting the response, review of deliverables, and ensuring actions continued beyond initial response.
  • Halloran performed verification of effectiveness of completed corrections and preventative actions and provided a third party assessment of the company’s commitment to address the issues thoroughly and effectively.
  • Halloran’s strategic leadership was requested to continue beyond remediation to support continuous improvement of their clinical quality system, operations, vendor oversight practices, integrated clinical program planning, and refinement of inspection readiness processes. 

VALUE
The company successfully resolved their 483 with no further warning letter action.   They were able to demonstrate commitment to FDA and investors in their ability to address quality issues quickly and thoroughly.  The company was geared up to begin their second study on time with an integrated risk-based clinical study plan in place outlining clear milestones, dependencies, accountability, and appropriate risk mitigations in place to prevent additional compliance issues.