NEWS & BLOGS

[FDA Warning Letter Files] Paperwork Isn’t Enough — The Real Meaning Behind FDA’s Quality System (QSR) Warning

Oct 30
3 min read

The FDA recently issued Warning Letters to two overseas medical device manufacturers, citing significant violations of the Quality System Regulation (QSR). This action is not a mere administrative notification; it sends a powerful message that the FDA is actively stepping up scrutiny of overseas manufacturing operations and their capacity for effective quality system management.

Both companies were found to have systemic failures in product testing and validation procedures, as well as inadequate management of quality records and documentation. The FDA pinpointed this as a 'structural inability to independently prove product quality.'

Key Takeaways from the FDA's Findings

The FDA's focus was not on simple errors or document omissions. The core of their message is encapsulated in this statement:

“It appears that your firm lacks the necessary procedures to ensure product quality and consistency.”

This is a direct indictment of the entire quality system structure, indicating a failure to function as intended. Specifically, the Warning Letters cited the following critical items:

Incomplete or Inaccurate Manufacturing Process and Testing (Validation) Records
Corrective and Preventive Action (CAPA) Procedures Existing on Paper but Not Functionally Operated
Deficiencies in Supplier Evaluation and Management Systems
Non-functioning Document/Record Control System, making Device History Record (DHR) traceability impossible

What Was the Real Problem? System Failure, Not Just Paperwork

The crux of this case is that the system was not operational, extending far beyond 'missing paperwork.' The FDA does not simply check for the existence of procedures. They demand objective evidence that those procedures are being actively implemented, and that corresponding documents and records exist to prove this operation.

While a quality system is, at its heart, a 'set of procedures for managing quality'. a system that is not operated renders its documentation meaningless. This recent action directly addresses and condemns this disconnect.

Manufacturers who receive a Warning Letter must submit a written Corrective Action Plan (CAPA) within 15 business days. Failure to respond or provide insufficient corrective action may lead to further sanctions, including import bans, verification inspections, and product recalls.

Through these steps, the FDA is intensifying its Post-market Enforcement. The focus is shifting from pre-market clearance and approval to the continuous maintenance of quality after a product is on the market. Manufacturers must demonstrate a "continually managed and proven system," not just a successfully registered or cleared product.

Essential Prevention Strategies to Avoid an FDA Warning

To preemptively guard against an FDA Warning Letter, medical device manufacturers must prioritize the following system checks:

✔️ Regularly review Design History File (DHF) and Device History Record (DHR), and ensure rigorous change history management.

✔️ Actively operate the CAPA procedure, leaving records of the execution and verification phases.

✔️ Ensure process and performance Validation documents are regularly updated, with robust supporting evidence secured.

✔️ Formally document and implement OEM/ODM Supplier Management procedures, clarifying quality responsibility and recordkeeping.

✔️ Conduct Mock Audits (simulated FDA inspections) to test documentation and processes under real-world pressure.

This case sends a clear, unambiguous message to all medical device manufacturers exporting to the U.S. market.

“The quality system must be a living system, not merely a set of documents for an inspection.”

The FDA is looking at 'Is the Quality System actually working?' with increasing stringency. Overseas manufacturers must move beyond simple document preparation and build a quality system where operation, verification, and record-keeping are organically integrated.