FDA Inspections: Prepare and Survive
Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance, and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. Mr. Uldriks understands how FDA thinks, how it operates, and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize the FDA’s domestic and international operational programs, institutional policy, and a thicket of legal variables into a coherent picture. His professional credentials include JD – Suffolk University, licensed in Massachusetts, and the District of Columbia; M.Div. in psychology – Boston University with an internship through Harvard University.
FDA conducts establishment inspections to determine a firm’s conformance to applicable regulatory requirements. Inspections vary based on the type of product you make or plan to make. FDA prioritizes domestic and foreign inspection assignments based on three factors. However, with the current public health crisis with COVID-19, FDA is overwhelmed with work at this time, so it will likely rely on new approaches to conduct inspections. The basic inspectional requirements and procedures remain the same. FDA presumes you know what you are doing, but you have to show them, i.e., trust but verify. There is no secret about what an investigator looks for. If you do not know, you will likely receive a list of observations that provide concrete examples of nonconformance. You can estimate the gravity of your situation using a few simple pointers.
- Purpose of an inspection
- FDA’s inspection compliance program for you
- Providing Information and documentation, or not
- Discussions with management
- FDA Inspectional “observations” – the 483
- Administrative and legal consequences
Who Should Attend
- Regulatory Affairs Directors and Managers
- Quality Assurance Directors and Auditors
- Manufacturing Directors and Managers
- Quality Control Managers
- Training Directors
- Document Control Managers
- Recall Managers
- In-house counsel
Why Should You Attend
You can demystify an inspection by using FDA documents and know where the FDA investigator will likely dig for problems based on changing policies. Your FDA “War Room” can relax, really. You can predict what the FDA investigator will do and based on what they find, how they will collect evidence against you. There are some documents that if collected are a very bad sign. At the conclusion of an inspection, you and FDA will discuss the bad things the investigator found. Most firms ask the investigator, “So, how bad was it?” They will not tell you, but you can figure that out yourself using standard criteria already established by the FDA. Consequently, you can lower your regulatory anxiety level and prepare a rational plan for responding to FDA, but even with that, there are some practical “pointers” to make your life easier. You can use a basic technique to quickly evaluate the gravity of a 483. It should take about 5 minutes. You will also take away pointers on what not to say or do during an inspection. FDA investigators can be a little sensitive.