Last Updated on December 21, 2024 by The Health Master
Warning
The U.S. Food and Drug Administration (USFDA) has taken a significant step to protect public health by issuing warning letters to two Chinese nonclinical testing laboratories.
These labs, located in Tianjin and Suzhou, were found to have serious deficiencies in their laboratory oversight and animal care practices.
Data Integrity and Quality Concerns
The USFDA’s inspections revealed a pattern of inaccuracies in data recording and verification at both laboratories.
This raises serious concerns about the reliability of the safety data collected from these facilities.
Such unreliable data could potentially jeopardize the premarket approval of medical devices.
Animal Care Violations
In addition to data integrity issues, the USFDA also identified violations related to animal care at one of the laboratories.
The lab failed to provide adequate care for the test animals, raising ethical concerns about the treatment of animals used in research.
Public Health
Owen Faris, acting director of the Office of Product Evaluation and Quality at the USFDA’s Center for Devices and Radiological Health, emphasized the importance of maintaining safety and quality within the medical device industry.
He stated that the USFDA will not tolerate any violations of regulatory standards and will take action to protect patients and consumers.
Ongoing Review and Corrective Actions
The USFDA is continuing its review of data submitted by these laboratories and has indicated that it will not authorize submissions using unreliable data.
The agency is also evaluating the potential impact on past submissions and will take further action if necessary.
Both laboratories have been instructed to submit corrective action plans within 15 working days.
The USFDA will closely monitor their progress in addressing the identified deficiencies.
Industry-Wide Reminder
Earlier this year, the USFDA issued a warning to the medical device industry about the importance of carefully reviewing data from third-party laboratories.
The agency stressed that outsourcing testing does not absolve sponsors of their responsibility for the accuracy of regulatory submissions.
Ensuring Public Health Standards
Nonclinical laboratory studies play a critical role in ensuring the safety and efficacy of medical devices.
The USFDA remains committed to ensuring the accuracy and reliability of such data, particularly when it comes to third-party laboratories.
By taking action against laboratories that violate regulatory standards, the USFDA is helping to protect public health and maintain the integrity of the medical device industry.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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