Do FDA “Virtual” Inspections of Domestic and Foreign Manufacturing Sites Endanger Americans?
As the Covid-19 Pandemic Rages On, FDA is Issuing a Pilot Program for “Virtual” Inspections of Domestic and Foreign Manufacturing Sites
UNITED STATES – According to medtech.pharmaintelligence.informa.com, the global pandemic is influencing the United States Food and Drug Administration (FDA) to implement a voluntary pilot program that will enable investigators to engage in virtual facility inspections. The creation of the voluntary pilot program is currently in the planning stage.
According to a lead quality systems and compliance expert has engaged in a discussion with the FDA’s director of compliance in the OMDRHO Division, and has indicated that the FDA is in the process of developing the pilot for a voluntary remote inspection program for devices. This expert has been employed for over 30 years in the FDA’s Office of Regulatory Affairs and Center for Devices and Radiological Health
Outside of the United States, virtual audits of manufacturing facilities have become the norm. Pursuant to the voluntary pilot program, it is unknown at this point whether the FDA will actually call them ‘inspections.’ The above expert indicates that there is a possibility that they will be called ‘visits.’ Since it is in the initial stages of development, the expert notes that the FDA does recognize the need for inspection programs for medical devices are warranted.
The main reason for the inspection programs is to address medications that are manufactured abroad, where their manufacturing sites and processes do not meet American regulations and safety standards. One such example of this is a drug called Metformin, which was recently found to be carcinogenic due to impurities found in the drug.
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