FDA 483 Warning Letters
Background
A mid-sized company received FDA 483 including 10 items of violation. The company responded but subsequently received a Warning Letter. This company was not sure how to best approach the FDA after their first pointed responses resulted in a Warning Letter. They were in need of medical device consultants who could provide insight and expertise.
Challenge
The FDA clearly set expectations for the manufacturing of drug and device products at this location. The management team had responded to the FDA 483 warning letters once, and was unsure how to respond to the second Form 483.
Approach
Regulatory Compliance Associates® (RCA) developed a phased program plan to address the Warning Letter and the larger quality systems challenges. The first phase provided the FDA with Warning Letter responses with aggressive completion timing and objective evidence detailing the completed commitments.
The second phase of the program assessed and corrected the overall quality system. A comprehensive plan with aggressive but realistic milestones was developed along with supporting tasks and task dependencies. Definition of roles and responsibilities and milestone ownership was determined early on in planning the project.
RCA provided a certified Project Management Professional (PMP) to lead the program, as well as engineers with expertise in quality systems and manufacturing engineering to execute the program in concert with client resources.
Result
The Warning Letter timing, responses, and objective evidence were received favorably by the FDA. The Warning Letter was closed out with the FDA within six months. Best-in-class project management methods employed in Phase II of the program helped to ensure success in achieving quality systems compliance milestones on time and within budget.
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