The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations involving data falsification, poor quality controls, and noncompliance with regulatory standards—raising red flags for medical device manufacturers that outsource premarket testing to overseas labs.
“The FDA has no room for bad actors,” said Commissioner Marty Makary, M.D., M.P.H. “False and shoddy activity jeopardizes patient access, product sponsors, and the device supply chain.”
What Happened?
After detailed inspections, the FDA found both labs—used for U.S. device submissions—violated Good Laboratory Practices (GLP) and failed to ensure test reliability. Read the news release here
Key Violations Identified:
- Data Integrity Failures: Incomplete, inaccurate, or untraceable test records
- Weak Quality Oversight: Lack of QA systems and supervision
- Animal Welfare Lapses: Poor documentation and animal tracking in biocompatibility studies
- Training Gaps: Unqualified personnel performing critical testing tasks
These issues compromise the credibility of data submitted in FDA filings—posing risks to manufacturers and patients alike.
Implications for Manufacturers
The FDA reminds manufacturers that they remain fully responsible for the integrity of the data they’re submitting. Companies relying on these “bad actors” could face submission rejections or re-testing requirements. To mitigate risk, the FDA urges manufacturers to:
- Reevaluate submissions tied to the cited labs
- Strengthen due diligence when selecting third-party labs
- Ensure traceability of all submitted test results
- Use FDA ASCA-accredited laboratories whenever possible
If your compliance testing has gone off track, don’t worry—we’re here to support you. Let us help you bring clarity and direction back to your project in the fastest, most cost-effective way possible. We understand that time is money.