CDRH Warns Three Foreign Medical Device Manufacturers

Regulatory News

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea.

Among other violations, the warning letter for Taiwan-based HMD Biomedical, which manufactures GoodLife AC 300-305 Self-Monitoring Blood Glucose, says the company did not establish and maintain procedures for validating the device’s design, nor did it provide training records demonstrating employees have been properly trained to conduct and document future inspections.

Korea-based Neo Vision, which manufactures daily wear soft contact lenses, received a warning letter with four violations in September 2016 following an inspection last May. CDRH said the firm failed to conduct design verification/validation procedures and failed to establish and maintain device history records (DHRs) for each batch, lot or unit to demonstrate that the device is manufactured in accordance with the device master record (DMR).

Given the serious nature of the violations, FDA says the daily wear soft contact lenses manufactured by Neo Vision will be refused entry into the US until the violations are corrected.

Meanwhile, China-based Implant Dental Technology received a warning letter in October 2016 after FDA inspectors last June found “unidentified green/brown particulate accumulation within the water tanks” used throughout the manufacturing process to steam clean dental implants.

The company was also cited for its failure to evaluate sources of quality data to identify the need for conducting corrective and preventive actions for several time periods during 2013, 2014 and 2015.

HMD Biomedical Inc. 8/31/16

Neo Vision Co., Ltd. 9/14/16

Implant Dental Technology Co., Ltd. 10/25/16