How to recover – Top FDA Findings

Findings are expensive!

Significant deviations result in significant damage. In addition to direct costs, such as notified body fees or additional personnel resources, there are a number of indirect (ill-structured) costs. These include significant remediation costs, loss of sales and market share, and reputational damage as warning letters are publicly visible. In addition, findings can lead to a loss of confidence among investors, customers and employees.

Top FDA Findings

There is currently no significant data available for Europe . However, it can be assumed that the situation is similar here. An additional challenge in implementing the MDR concerns the requirements for clinical data.

21 CFR 820.100(a) – CAPA Procedures
21 CFR 820.198(a) – Complaint Management
21 CFR 820.90(a) – Nonconforming Products
21 CFR 820.50 – Purchasing Control
21 CFR 820.100(b) – Documentation of CAPA activities and results

(FDA Inspection Observation FY 2023)

What is an FDA Form 483?

Once the inspection by FDA investigators has been completed, the company will receive a 483, which documents all the deviations that have been identified. These will be read out immediately afterwards and discussed with the company’s management. Please note that this is NOT the Establishment Inspection Report.

FDA Form 483 – what now?

We highly recommend to respond to the 483 in an appropriate manner. Taking this situation seriously is essential to avoid escalation into a warning letter. Make the necessary resources available and set up a Task Force to ensure that the findings are adequately addressed and resolved. A response must be submitted within 15 business days and should come directly from management. This response should include a detailed and systematic description of the cause(s) of the deviations and the measures taken to eliminate them.

FDA Warning Letter

Warning letters are typically issued for two reasons. Either the response to the FDA Form 483 was inadequate, or the deviations are serious enough to violate the law and require immediate action. Warning letters are published on the FDA website and can have far-reaching consequences. These include a direct impact on current or planned submissions, as well as being placed on the import hold list, effectively removing your products from the U.S. market. In the most serious cases, the FDA may take additional action, including seizing the product and pursuing criminal charges.

What is Remediation?

Remediation refers to all measures taken to eliminate significant deviations and recover compliance. Our recommendations are as follows: Immediately notify the FDA by registered mail that you will respond adequately to the warning letter within 15 business days. Set up a task force consisting of internal and/or external experts and create a comprehensive CAPA plan with a clearly defined timeline. It is equally important to prepare for a possible follow-up visit.

Remediation – Task Force

It may be beneficial to consult an external task force of experienced remediation experts to get an unbiased view from an outside perspective. We know the current regulatory requirements and guidelines inside out and can help you develop a coherent CAPA plan. With our many years of experience in conducting gap analyses, we are well equipped to identify and address any nonconformities. If you have any questions or are looking for support, please do not hesitate to contact us.