“I’ve had the pleasure of working with The FDA Group on Quality System matters as they pertain to the FDA. The FDA Group was brought in to perform a thorough gap analysis in several areas of our quality system, to suggest mitigations for these gaps, and to help with Quality System training to ensure that the proposed mitigations were properly understood and implemented.
I found The FDA Group to be particularly well-matched for the needs of our small operation, as they took pains to thoroughly understand the details of our existing processes and to reshape these in a way that satisfied the necessary requirements while minimizing the impact to the existing workflow. Their intimate familiarity with the many requirements made our exchanges efficient, as they could quickly steer the discussions towards providing effective solutions without pausing to research the details of the regulations. Their experience as a trainer/teacher for lead auditors facilitated our discussions, as they presented information in a clear and uncomplicated way, often supporting it with varieties of the materials and practical examples.
In addition to their wide breadth of knowledge, I found them to be very professional and respectful in their demeanor, mindful of the company’s needs and resources, and flexible in working around our schedule to accommodate our needs. They communicated clearly, were well-organized and were very accessible. On a personal note I found our exchanges to pleasurable and insightful.
Based on my experience with The FDA Group, I have no reservations in recommending them for matters related to Quality System development, implementation, compliance, and maintenance. Given the opportunity I would gladly work with The FDA Group on future projects.”
“Due to a pending marketing application, our company found itself in the position of expecting a follow-up, not-for-cause FDA audit. In preparation for this event, we decided that the most relevant assessment could only be performed by ex-FDA personnel. The FDA Group was therefore contacted specifically for this purpose. They were able to accommodate our short schedule and provided us with an excellent, highly experienced ex-FDA auditor. She performed a targeted, two day gap analysis audit whose results not only reinforced our confidence in our quality system but resulted in a valuable task list containing system elements that could be significantly streamlined while maintaining compliance. All told, we found The FDA Group to be accommodating, a good value, and competent. Highly recommended.”
“I am writing to commend you and your organization in helping us prepare for our PMA pre-approval inspection audit. Your advice in helping us select a qualified auditor was invaluable in providing us with the insight to prepare for the FDA. The FDA Group’s strength lies in your attention to our needs and finding the right talent to meet those needs. I appreciate your staff’s customer service in making what is usually a very hectic process easier, from arranging travel to coordinating agendas.
Thank you in being an integral part of our road to success. Your work has also qualified The FDA Group to be on our Approved Supplier list.”
“When we decided to pursue FDA approval for a new medical device, we did not know where to begin. Luckily, some cursory research led me to a call with The FDA Group, LLC. They did an excellent job of explaining the process and keeping me well informed every step of the way. They completed the project early and came in under budget. I would highly recommend The FDA Group, LLC for all your regulatory needs.”
“I wanted to thank you for the assistance The FDA Group provided in helping us to prepare for an FDA Inspection for PAI, GCP and also at our Device Contract Manufacturer by conducting Mock FDA Audits. The auditors were all very professional and experienced and provided valuable insight into the expectations of the FDA prior to an inspection. In addition, the cost of the auditing services never exceeded the amount originally quoted, which has not been my experience with other contract auditor services. I would recommend The FDA Group for contract auditing services including Mock FDA inspections for both PAI/GMP and GCP.”
“I would like to thank The FDA Group, LLC for providing the right resource to perform audits both at our headquarters and at our contract manufacturer. This was to prepare us for an upcoming FDA audit associated with a PMA submission. The resource provided had just the proper balance of seasoned FDA and industry experience. This resulted in prompt and thorough audits that identified and prioritized opportunities for improvement while being performed on time and under budget. The FDA Group will be at the top of my list going forward when I have FDA related Quality System needs.”
“To all who are considering doing business with The FDA Group, we would recommend them with no hesitation. The FDA Group is very professional and does business promptly. They responded to us at all hours of the day or night if we were trying to resolve a situation and move ahead. We know you will be satisfied with the project done for you.”
“We are a contract manufacturer of implantable medical devices and surgical instruments. As such, we are registered with the FDA as a contract manufacturer and are subject to Quality System Regulation compliance, 21 CFR, Part 820.
Prior to working with The FDA Group we had completed (4) prior FDA investigations. The most recent investigation had completed with several 483 Observations, all which required corrective actions.
Our experience working with The FDA Group has been excellent. Their consultants are knowledgeable and experienced. With the help of The FDA Group, we studied our quality systems and made improvements where necessary.
After The FDA Group’s support, we completed yet another on-site FDA investigation. However, this time we had “No observations noted, and no FDA 483 Observations issued”. We could not have achieved this success without the guidance from The FDA Group. I strongly recommend The FDA Group for all FDA Compliance issues.”
“It is my pleasure to communicate to you how successful and positive our engagement has been with your organization. Our company, as a holder of FDA Registrations with unique credentials as a joint Commission Accredited Ambulatory Telehealth Provider and as an Approved Center for Medicare and Medicaid (CMS) Independent Diagnostic Testing Facility, were faced with improving a very complex Quality System. Specifically, our company needed support to address a FDA Warning Letter. The FDA Group’s guidance, professional interaction, and expertise meet this large need.
The FDA Group provided our organization with a detailed GMP audit and identified our areas of strength, but most importance the areas requiring improvement to ensure that all gaps and deficiencies were addressed immediately and in the future. The assigned expert contractor’s vast experience with the FDA regulations and Quality gave our organization new insights into how we could be voluntary compliant with all standards, while at the same time balancing the needs of the company’s clients and our other regulatory agencies demands.
I am pleased to report that today we believe that our organization’s Quality System is greatly improved and most importantly we believe that the FDA is completely satisfied that we have addressed all issues that lead to the company receiving a warning letter. It would be my pleasure to provide a reference and recommend your organization at any time.”
“I wanted to let you know how impressed we are with The FDA Group. Your knowledge, thoroughness, and ability to work with our staff was very impressive. You were extremely informative and well received by our all of our staff. We really appreciate your effort to coordinate the visit. This is the type of interaction that builds a strong relationship and your organization is on the top of our referral list. We look forward to the report as well as a continued relationship with The FDA Group.”
“Working with The FDA Group is a learning experience for all involved! We had them in twice for mock FDA Inspections. We not only learned more about compliance but also learned a lot about benchmarks and what is being observed in the best in class organizations. I highly recommend The FDA Group to any device company that is serious about quality, regulatory and compliance!”
“The three of the folks who performed our work did a fantastic job and did what was asked of them. In fact, they did a bit more then what was required which will ultimately help the site in the long run. The site does appreciate their efforts. I would recommend them again for this type of work or something similar.”
“The FDA Group was able to support our urgent business need in a short period of time. What I thought would take weeks only took a few days. A qualified ex-FDA inspector that met our requirements was provided to our project team in just a few short days. The project had a successful outcome and the team was very happy with the results and support from the resource(s) provided by The FDA Group.”
“I wanted to personally thank you for The FDA Group consultant’s support and participation, as an external Subject Matter Expert and presenter during our annual training. We are still working on metrics for the event, however all feedback received so far has been totally positive. Our attendees were delighted with the topics and presentations from all of the presenters. It is our goal to combine technical and compliance training during these events and throughout the year to create and maintain a Compliance Mindset and Quality Culture that we can be proud of.”
“Thank you for your timeliness with deliverables. It was my pleasure to meet you and work with you.”
“Thank you for keeping your eyes open for new FDA guidance documents. That is always helpful.”
“As a small and innovative organization with a Class III medical device in the PMA process we had the need to prepare for FDA PAI audits of both our headquarters and our contract manufacturer. We reached out to The FDA Group who identified a resource to perform the necessary audits. I am very pleased with the results. The resource had extensive prior FDA and industry experience and was easy to work with. He performed thorough and professional audits and provided a list of actionable recommendations. As a result we now have an increased level of readiness for the upcoming FDA PAI audits. I highly recommend use of The FDA Group as a source of FDA expertise. ”