UK medical device company banned from importing to US

Bedfont Scientific has been added to the US Food and Drug Administration’s (FDA’s) quality system import alert list for medical device companies

Bedfont is a UK based company that sells breath test monitors, nitric oxide and carbon monoxide monitors and medical pipeline testing equipment.

The company is now on the FDA list as RAPS reported that it did not meet the FDA’s device quality system requirements.

The FDA said: “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).”

10 UK companies are now on the quality system import alert list which also includes companies from 26 other countries.

The FDA said: “Foreign manufacturers listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions and/or practices that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

“This may include a letter detailing its corrective actions, accompanied by documentation.”

However, Jason Smith, general manager at Bedfont Scientific said: “We respect the FDA’s duty to ensure products are compliant and have provided a corrective action report.

"This is a first for Bedfont but respectfully, we are trying to remain in compliance with the increasingly complex regulatory world, whilst trying to always innovate our products to help improve the world’s health.”