UK Firm Bedfont Scientific Banned from Shipping Medical Devices to U.S.
The US Food and Drug Administration (FDA) has added UK-based Bedfont Scientific to its import alert list for medical device companies that have not met device quality system requirements.
Bedfont is now banned from shipping its products to the US, which includes its breath test monitors, nitric oxide and carbon monoxide monitors, and medical pipeline testing equipment.
“Foreign inspections of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMPs),” FDA says.
Bedfont is now banned from shipping its products to the US, which includes its breath test monitors, nitric oxide and carbon monoxide monitors, and medical pipeline testing equipment.
“Foreign inspections of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMPs),” FDA says.