mdi Consultants
This week the commissioner of the FDA released a new update regarding the effects and response of the FDA in relation to the Coronavirus. The FDA has emphasized that they are taking a multi-faceted approach to this public health emergency. This approach includes facilitating efforts to diagnose, treat, and prevent the disease; surveilling the medical product supply chain for potential shortages and disruptions and helping to mitigate such impacts; and leveraging the full breath of their public health tools to stop any fraudulent activity to oversee the safety and quality of FDA-regulated products for American patients and consumers.
While the FDA is not able to conduct inspections in China at this moment, the FDA reiterates that this is not hindering their efforts to monitor medical products and food safety. At the moment, risk-based inspections in other parts of the world are being prioritized. As soon as the travel advisory is changed, the FDA is prepared to resume routine inspections as soon as feasible. Import screening, examinations, sampling, import alerts are currently being used to complement inspections in addition to relying on a firm’s previous compliance history. A wide variety of FDA-regulated products are imported from China, which is why the FDA is taking all measures possible to assure the public of the quality of these products.
The FDA will also utilize their authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China. These records will help the agency when drug inspections in China resume by allowing the agency to take a risk-based approach to prioritizing inspections when they resume. In addition to records requests, the FDA will be continuing to work closely with the US Customs and Border Protection to target products intended to import into the US that may violate any applicable legal requirements for FDA regulated products. The FDA reserves the right to refuse admission of products that fail sample testing or may violate any other applicable legal requirements.
COVID-19 Transmission
At this moment, the FDA has announced that they have not seen any significant impacts of this outbreak resulting in any increased public health risk for American consumers from imported products. There has also been no evidence to support transmission of COVID-19 associated with imported goods but this remains a dynamic situation and it will be continually assessed.
The FDA is also aggressively monitoring the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. Any firms who are believed to deceive the public and take advantage of a crisis could be subject to warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms who violate the law.
mdi has experienced FDA’s changes in plans for several of our Chinese clients concerning their upcoming inspections. The FDA postponed all FDA inspections with no rescheduling. WE have also seen and increase in foreign inspections in Canada, Europe and Israel. Though, some plans in the Europe may now be changed as well.
As more information is available, mdi will be closely monitoring the situation and will be posting more updates. If you have any specific questions regarding the coronavirus outbreak and how it may affect your company’s operations feel free to contact us via email at [email protected] RE: Coronavirus.