FDA Warning Letter Rescue
A mid-sized medical device manufacturer received an FDA warning letter. Cerulean was contacted over other consulting firms for several reasons, in the words of their president:
“First, Cerulean’s experience in dealing with our specific issues of quality management. Second, Cerulean’s expertise with small and mid-sized manufacturers meant a greater understanding of how to apply cGMP and QSR to companies like ours. Lastly, the proposal that Cerulean submitted was clear, detailed, and expressed a complete understanding of the work ahead.”
Understanding how to balance business realities with FDA compliance is critical. Consultants who talk about solutions such as “just get another supplier” or “you need lots and lots of SOPs,” only demonstrate they know one side of the equation. They don’t know how to solve it. We do. Cerulean specializes in cost-effective FDA compliance for small companies, mid-size firms, and single site divisions.
Do want your compliance programs to be overhead or cost-effective? Do you want a consultant who’s focused on your success? Here’s what the president of our client said:
“John Avellanet at Cerulean came to our rescue. We started as a small medical device supplier to the US Defense industry and quickly grew into a company with over twenty products. Our processes were not keeping up with our growth. When we received a warning letter from the FDA, John was there for us. He guided us through the process of bringing us compliant with the QSR and cGMPs, and helped us through the follow-up and closeout letter inspection. Cerulean was there for us from start to FDA approval.”
– Paul Harder, President, Gloucester, Virginia
If you’re looking for an FDA consultant that understands how to balance business and compliance, contact us today. Cerulean is here to help you succeed.