The U.S. Food and Drug Administration (FDA) has issued warning letters to two Chinese firms concerning lab practices potentially impacting data produced by the lab.
The letters were issued to Mid-Link Testing Company, Ltd in Tianjin, China, and Sanitation & Environmental Technology Institute doing business as SDWH in Suzhou, China. The letters were issued on September 10 and the FDA requested that within 15 days of receiving the letters the firms notify the FDA of the corrective actions to be taken. According to the FDA press release, both firms provide “third-party testing and validation data services to device manufacturers for use in their premarket device submissions to the FDA.”
In the FDA press release, Acting Director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, Owen Faris, Ph.D., commented on the matter. Dr. Faris stated, “The medical device industry must be built and sustained on safety, effectiveness and quality.”
Dr. Faris continued, “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.”
The letter to Mid-Link Testing Company provided notice of “objectionable conditions” observed during an FDA inspection earlier in the year. According to the FDA letter to Mid-Link Testing Company, the FDA investigators focused on certain studies conducted at the facility including “acute systemic toxicity and rabbit pyrogen tests.”
The letter to Mid-Link Testing Company indicated issues with the following: quality assurance of the data; a “failure to conduct nonclinical laboratory studies in accordance with the protocols”; a failure of adequate standard operating procedures; a failure to ensure that “personnel clearly understand the functions they are to perform”; a “failure of the Quality Assurance Unit (QAU) to fulfill responsibilities”; and a “failure to ensure that warm-blooded animals shall receive appropriate identification.”
The letter to SDWH similarly provided notice of “objectionable conditions” observed during an FDA inspection earlier in the year. According to the FDA letter to SDWH, the FDA investigators focused on certain studies conducted at the facility including “guinea pig maximization sensitization, acute systemic toxicity, complement activation, hemolysis, and cytotoxicity tests.”
The letter to SDWH indicated issues with the following: a failure by the study director to assure that necessary protocols and practices were followed; a failure to assure that there was a quality assurance unit as required by regulations; a “failure of the Quality Assurance Unit (QAU) to fulfill responsibilities”; a failure to ensure the necessary education, training, and experience of all individuals engaged in the nonclinical laboratory study; a failure to have standard operating procedures in writing; and a failure to “ensure that all newly received animals from outside sources were isolated and their health status evaluated in accordance with acceptable veterinary medical practice.”
