CDRH Sending Warning Letters to 3 Foreign Medical Device Manufacturers
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.
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.