FDA Warning Letter Resolution

The Partnership

Was established by a medical device firm to resolve significant GMP observations and change company culture

The Need

  • Completely resolve FDA issues and restart operations.

  • An appropriate number of hands-on, skilled colleagues that would lead change and perform.

  • Ability to meet aggressive timelines.

  • Culture change catalysts for all levels of employees.

The Process

Collaborated on the response, timeline and compliance actions to mitigate the situation.

Dedicated, Skilled Team

Customer centered support with focus on re-establishing the credibility of our partner with the FDA.

Apply FDA Expertise

Collaborated on the response, timeline and compliance actions to mitigate the situation.

Enhance Existing Systems

Improvements developed by a collaborative effort with our partner on existing Quality Systems.

Company Cultural Shift

Top down / bottom up adult learning program to understand and remediate the causes of non-compliant activities.

Complete Transformation

Communicated with FDA and provided periodic reports. Complete, effective systemic evolution.

Successful Results

Warning Letter resolution and no further FDA actions. Company quality culture shift that empowered all employees. Common-sense, practical system enhancements that eliminated waste and improved performance.

Gain Our Insight

LET'S GET STARTED
Top