[Editor's note from 2/25/16: This article has been updated with comment from Bedfont.]
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.
A total of 10 UK companies are now listed on the quality system import alert list, which also includes companies from 26 other countries, including Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Peru, Spain, Switzerland, Taiwan and Thailand.
“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,” FDA says.
In response to the
recent US Food and Drug Administration’s (FDA) decision to temporarily detain
Bedfont products without physical examination Bedfont Scientific’s General
Manager and long-term American Distributor have spoken.
Jason Smith, General Manager at Bedfont Scientific, told Focus: “We respect the FDA’s choice to provisionally interrupt Bedfont importing into the USA, it is their duty to ensure products are compliant. We have welcomed the opportunity to provide a corrective action report and in fact have corrected most of the observations since our FDA audit in September 2015, within the 15 day period provided in order to lift the momentary detainment. This is the first time in 40 years we have had to handle a matter such as this but respectfully, we are trying to remain in compliance with the increasingly complex regulatory world, whilst trying to always innovate out products to help improve the world’s health.”
Jason Aversano, spokesperson for CoVita, Bedfont's US distributor, added, “I have personally been working with Bedfont
Scientific since 1988 and know the high quality of their products is unanimous
worldwide. CoVita has every confidence that Bedfont Scientific will resolve
these minor regulatory observations that are an unfortunate side-effect with
products that are always evolving to best meet consumer’s needs.”
Import Alert List
Other Regulatory Device News in Brief
FDA on Tuesday also updated its safety communication to Custom Ultrasonics, reinforcing the terms of the recall order for its automated endoscope reprocessors. “Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that health care facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible,” FDA said.
The agency also extended its comment period by 30 days on draft guidance for interoperable medical devices.