FDA Issues Warning Letters to Chinese Testing Labs

Two more Chinese companies providing contract services to medical device OEMs have come under FDA scrutiny.

The agency reported today that it has issued warning letters to nonclinical testing labs Mid-Link Testing Company Ltd. in Tianjin and Suzhou-based Sanitation & Environmental Technology Institute of Soochow University Ltd., citing them for laboratory oversight failures and animal care violations. The firms provide third-party testing and validation data services to device manufacturers for use in their premarket device submissions to FDA.

Data integrity in question

The agency inspected the firms earlier this year and found pervasive failures with data management, quality assurance, staff training, and oversight. The failures raise concerns about the quality and integrity of data generated by the labs, said the agency in a press release.

Earlier this year, FDA issued warning letters to China-based plastic syringe manufacturers, whose products are marketed and distributed in the United States by Medline and Sol-Millennium Medical. The syringes were plagued with quality issues, such as leaks and breakage, that may affect the ability to deliver the correct amount of medication.

Unreliable data in premarket device submissions

During its inspection of the testing labs, FDA observed failures to accurately record and verify key research data, which brings into question the quality and integrity of safety data collected at the facilities, said the agency. These failures could lead to the use of unreliable data in premarket device submissions.

The warning letters also note violations related to test animals. One firm is cited for failing to provide adequate care for the animals, and both firms failed to provide adequate identification and recording of the animals used in the labs' testing.

“Nonclinical laboratory studies are experiments in which test articles are studied prospectively in test systems (such as animals, plants and microorganisms or subparts thereof) under laboratory conditions to determine their safety,” explained FDA in the press release. “While a device sponsor may use a third-party lab for nonclinical studies, doing so does not relieve the device sponsor of the responsibility to ensure the accuracy of data included in their regulatory submission.”

The device sponsors were not named by FDA.

Protecting the medical device supply chain from quality failures

"The medical device industry must be built and sustained on safety, effectiveness, and quality," said Owen Faris, PhD, acting director of the Office of Product Evaluation and Quality in the FDA's Center for Devices and Radiological Health. "The FDA will take action to protect patients, consumers, and the medical device supply chain from quality failures and violative practices. We strenuously remind industry of their responsibility and accountability for all data included in their submissions, which are required to comply with federal law."

Recipients of FDA warning letters must notify the agency of corrective actions they have taken within 15 working days of receiving the letters.