FDA Warning Letter & 483 Remediation

Our client was issued an FDA 483 Form and tasked our team with the challenge to rectify and reform their current company practices. Our team performed a comparative analysis of the company based on FDA observations to develop a strategic remediation portfolio encompassing over 70 projects that effectively targeted all major deficiencies across various departments. To maintain the company’s strong foundation while still addressing FDA concerns, we developed a master remediation schedule using CPM techniques, WBS charting, task dependency identification, and risk management techniques. The schedule included a minimum of engineering, operations, management activities, etc. while addressing obstacles to successfully implement changes. This allowed resources to establish an allocation plan that used critical parameters, like an influx of documentation and utility installations, to support productions test runs and validations.

Transparency of remediation goals, strategy steps, and effective communication across departments were essential to ensure effective task management and production of deliverables. Utilizing powerful management tools, extensive quality knowledge, and strategic planning, our consultants successfully managed and collaborated with the client’s teams to address all requirements and concerns of the FDA 483 issuance.