CDRH warns 5 device firms in US, China, Hungary, Thailand and Taiwan
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released five warning letters sent to medical device manufacturers around the globe due to various violations.The release comes as device warning letters plunged nearly 90% over five years and as CDRH only issued nine warning letters in all of 2019.
US
For Nevada-based Steiner Biotechnology, an investigator from FDA’s Office of Bioresearch Monitoring Operations took issue with the way the firm conducted animal studies in rabbits for its Skeletal Graft and Ridge Graft devices during an inspection last June.
“You performed repeated, multiple surgeries on the same animals over time in both of your nonclinical studies. Neither the study protocol for studying Skeletal Graft nor the study protocol for studying Ridge Graft stipulates that the animals may be used in this manner,” the warning letter says.
FDA also noted that because rabbit bones are fragile and the tibia bones are in weight-bearing limbs, “creating four, simultaneous, critical-sized defects repeatedly in the tibias puts the animal at risk of unwanted bone fractures. The increased risk of bone breaks on the weight-bearing limbs is both an animal welfare concern and a confounder for both studies,” the agency adds.
In addition, the warning letter notes that Steiner’s quality assurance unit lacked the proper documentation, and nonclinical study specimens were not appropriately stored.
China
The warning letter for Dongguan Microview Medical Technology Co. notes that an inspection last June uncovered multiple violations that means the firm’s “Disposable Endoscopic Cannula” will be refused entry to the US.
The inspection uncovered “bins of finished devices and subassemblies” that lacked the product identification and/or acceptance status labels, as well as “unidentified bins of components stored on the floor in the ultrasonic cleaning room; also, the status of the components as to whether they were cleaned or awaiting cleaning was not identified.”
Hungary
FDA’s inspection last October of Hungary-based Mandelay Kft uncovered deficiencies that led the agency to determine that the firm’s “Scientific Consciousness Interface Operation (SCIO) System and the Quantum University Energetic System Technology 9 (Quest 9)” devices should be refused admission to the US.
The warning letter says the firm’s design control procedures, noted in its quality manual, have not been adequately implemented. In addition, FDA says software-related complaints are only handled via telephone and not documented or investigated appropriately.
Thailand
Condom manufacturer Okamoto Rubber Products Co. received its warning letter in February after FDA found issues with the firm’s corrective action procedures. For instance, the firm revised a corrective action procedure but only approved it in English and not yet in the native Thai language used for the firm’s quality system.
FDA also said the firm has not addressed how and/or why it failed to implement an updated corrective and preventive action procedure in the Thai language for over two years. Additionally, no documentation of any updates or employee training has been submitted to FDA for review.
Taiwan
This warning letter dated 2 March for E-Care Technology Corp. is related to a Class II thermometer that FDA says is adulterated and will not be allowed into the US.
Among the violations, FDA noted repeat observations from 2015 and said the firm’s risk management report “did not identify all potential failure modes/risk mitigations” and that its “sampling plan is not based on a valid statistical rationale.”
Warning letter for Steiner Biotechnology, LLC
Warning letter for Dongguan Microview Medical Technology Co., LTD
Warning letter for Mandelay Kft
Warning letter for Okamoto Rubber Products Co., Ltd.
Warning letter for E-Care Technology Corp.