How Non-Compliance Can Impact Medical Device Manufacturers—and What You Can Do to Prepare
Process validation is a critical requirement for medical device manufacturers. The FDA routinely issues Form 483s and Warning Letters when companies fall short in this area, underscoring the importance of robust validation protocols. Since 2020, there have been at least 43 documented instances where the FDA cited non-compliance with a key regulatory requirement: “Failure to validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR §820.75(a).”
Recent Examples Highlight Common Validation Pitfalls
Here are two examples of common validation pitfalls we see highlighted in Warning Letters. In the first, a manufacturer of diagnostic devices received a Warning Letter after an FDA inspection that cited significant gaps in their validation efforts. Specifically, the Operational Qualification (OQ) and Performance Qualification (PQ) protocols for the Heat Sealer and Packaging processes lacked essential seal integrity testing. Instead, they relied solely on testing and visual defect inspections. Additionally, the calibration range of the test equipment did not fully encompass the conditions used during the validation study, further compromising the validity of the results.
Similarly in the second example, when the FDA inspected a manufacturer of pulmonary and cardiovascular medical devices, they found that the cleaning and disinfection process for one of its pulmonary devices, used both during production and by end-users before and after patient contact, had not been validated. This lapse was particularly concerning given the critical role of disinfection in ensuring patient safety.
Why FDA Responses Matter
In both cases, the FDA reviewed the companies’ responses and deemed them inadequate, because the company’s responses did not thoroughly outline the details of actions being taken. These examples serve as a reminder that simply responding to FDA findings isn’t enough; your remediation efforts must address the root causes and demonstrate full compliance with regulatory expectations.
How BioTeknica Can Help
At BioTeknica, an IQVIA business, we understand the complexities of FDA regulations and the challenges of process validation. Our team offers the technical expertise and experienced resources needed to identify gaps, implement effective remediation strategies, and ensure your organization is thoroughly prepared for upcoming FDA inspections. Don’t wait until a warning letter arrives. Proactive validation and compliance are essential to safeguarding your products, business, and the patients who depend on them.
About Author, Saeid Ebrahim, Sr. Consultant
Saeid is a seasoned expert with more than 30+ years of experience in the medical device and in vitro diagnostics (IVD) industry. His career is distinguished by significant achievements in product and process validation and substantial involvement in third-party audits. Saeid has successfully managed and contributed to numerous projects, serving as both a hands-on Validation Engineer and a Project Manager, roles in which he has developed deep and practical domain expertise.
Highly proficient in statistical methodologies such as Process Capability, Gage Repeatability and Reproducibility (Gage R&R), and Design of Experiments (DOE), Saeid applies these principles in conjunction with his strong technical background to deliver reliable, sustainable, and FDA-compliant results. His dedication to quality assurance, regulatory compliance, and continuous improvement has established him as a trusted professional who supports the successful development and commercialization of safe, effective medical devices and IVD products.
