FDA Warning Letter Breakdown: A Quality System Collapses at a Blood Collection Device Manufacturer
A recently posted warning letter reveals systemic failures—and critical lessons—for device manufacturers on validation, design controls, and supplier management.
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A recently issued FDA warning letter offers a few sobering lessons for medical device manufacturers across multiple quality system elements—the same elements we find firms struggle with in our own audits and mock inspection work.
The letter was issued to a German medical device company specializing in blood collection systems, specifically a capillary blood collection system.
The warning letter resulted from an inspection conducted between January 6-9. What makes this case particularly instructive is the breadth of systemic failures spanning process validation, equipment qualification, design controls, CAPA management, nonconforming product control, supplier management, and MDR compliance. These systems are deeply interconnected, and when they fail, those failures tend to cascade across the systems.
As a result of these violations, all devices manufactured by the firm are now subject to detention without physical examination at U.S. borders.
Let's examine each violation and extract a few actionable lessons that commonly make their way into our own audit reports.
Process validation failures
The firm was cited for failing to validate critical manufacturing processes as required by 21 CFR 820.75(a)—a core breakdown in process control for their product.
The company manufactures blood collection systems that are filled onsite with anticoagulant coated on capillary rods, a critical component that directly affects the device’s performance. Despite having a validation procedure that explicitly requires existing machines used for medical device production to undergo installation, functional, and performance qualification, the machines had never been validated.
In a pretty stunning revelation, these machines had been in use for 30 years without validation. When questioned during the inspection, the Supervisor of Quality stated they were "still trying to figure [out] how to retrospectively validate them."
Even more concerning was a software validation failure. The company's procedure required that software used in manufacturing be validated, yet the software used to inspect coated capillary rods was—again—never validated. During the inspection demonstration, the software accepted capillary rods that were outside specifications, a critical failure that should have resulted in rejection. Management confirmed this software had been installed "many years ago" and remained invalidated.
The lesson here should be very clear: Process validation isn't a “nice-to-have”—it's the foundation that ensures your manufacturing processes consistently produce devices meeting quality specs. When you've operated for decades without proper validation, you're essentially flying blind, with no assurance that your products meet their intended performance characteristics.
When we step into a facility and find similar “legacy system” challenges (to put it diplomatically), the path forward requires:
Immediate risk assessment. Evaluating all unvalidated processes to determine patient safety implications.
A phased validation approach. If there are a number of systems needing validation, but limited resources to do so, we prioritize validation based on product risk and process criticality, making sure everything receives the attention it needs in a logical order.
Interim controls. This often means implementing enhanced monitoring and testing until validation is complete.
Documentation standards. Establishing clear validation protocols that meet current regulatory expectations.
Ask yourself:
Can we demonstrate that all critical manufacturing processes have been properly validated?
For legacy equipment, do we have documented validation or qualified justification for continued use?
Does our software validation program cover all manufacturing and quality control applications?
How are we making sure validation remains current as processes evolve?
Equipment qualification disasters
The equipment qualification failures outlined in the letter went beyond mere paperwork violations—they directly contributed to product defects that reached customers.
One of the firm’s CAPAs documented machine failures that resulted in damaged capillaries in finished products for multiple batches. The root cause was identified as equipment failure, yet these machines had never been qualified for their intended use. When investigators asked about qualification status, management confirmed that validation plans were "still in process and have not been executed."
This is a textbook example of how equipment qualification failures create a terrible domino effect: Unqualified equipment leads to product defects, which trigger customer complaints, which consume valuable resources in firefighting mode rather than preventing problems.
The critical insight here: Equipment qualification isn't just regulatory compliance—it's your assurance that your manufacturing equipment can reliably produce conforming product. When equipment isn't qualified, you're essentially gambling with product quality and patient safety.
Ask yourself:
Do we have documented evidence that all manufacturing equipment has been qualified for its intended use?
When equipment failures occur, do we reassess qualification status as part of our investigation?
How do we ensure new equipment is fully qualified before production use?
Do our qualification protocols address all critical performance parameters that affect product quality?
Design control system breakdowns
The design control violations revealed a company operating without fundamental design management processes required for any kind of medical device manufacturing.
The firm didn’t have adequate design control procedures detailing design input, design output, verification, validation, transfer, review, and design history. Its existing procedures consisted of basic flowcharts and change lists that failed to describe how the company manages device changes to ensure product quality remains unaffected.
Maybe most alarming, the company couldn't produce design history files for its blood collection system. When investigators requested initial design documents addressing original design input, output, verification, validation, and design review records, the Supervisor of Quality stated the firm "may not have maintained such documents."
We often talk about documentation problems. This is not a documentation problem—it's a fundamental inability to demonstrate that a device was systematically designed to meet user needs and safety requirements. Without DHFs, a company simply cannot prove its device was developed using controlled processes or demonstrate that design changes haven't compromised safety or effectiveness. It’s that simple.
Operating without proper design controls means you can’t demonstrate that your device was designed to be safe and effective. This creates enormous liability exposure and regulatory risk.
Ask yourself:
Can we produce complete design history files for all devices we manufacture?
Do our design control procedures address all elements required by 21 CFR 820.30?
How do we ensure design changes are properly evaluated for their cumulative impact on device safety and effectiveness?
When was the last time we conducted a comprehensive assessment of whether our design changes require new 510(k) submissions?
Nonconforming product control failures
This part of the warning letter revealed a system that couldn't properly manage products that didn't meet specifications—obviously a critical quality control function.
While the company had a procedure defining responsibilities for nonconforming product review and disposition, it failed to document disposition decisions according to its own procedures. The specific example wasn't fully detailed due to redacted information, but the pattern suggests nonconforming products weren't being properly identified, segregated, and dispositioned.
If you can't properly control nonconforming product, you risk shipping defective devices to customers. This represents both a patient safety risk and a regulatory compliance failure.
Ask yourself:
Can we demonstrate that all nonconforming products are properly identified, documented, and dispositioned?
Do our records show clear decision-making rationale for how nonconforming products were handled?
How do we ensure nonconforming products don't inadvertently enter the distribution chain?
Supplier management inconsistencies
The company's supplier evaluation procedure classified suppliers into risk categories A through D, but suppliers providing similar critical components received different classifications.
For example, two suppliers providing identical materials for the blood collection system—both acknowledged to have "direct influence on the conformity of the medical device and the quality of the device"—were classified as Category A and Category B respectively. This inconsistent classification led to different quality agreement requirements for suppliers providing functionally identical materials, creating unnecessary supply chain risk and potential quality variations.
Supplier classification must be based on objective risk criteria, not arbitrary decisions. When suppliers provide materials with identical risk profiles, they should receive identical oversight and quality requirements.
Ask yourself:
Are our supplier classifications based on documented, objective risk criteria?
Do suppliers providing similar critical materials receive consistent oversight and quality requirements?
How do we ensure quality agreements are appropriate for the risk level of supplied materials?