FDA To Continue Remote Audits At Least Through The Rest of the Year
[Thursday, August 20, 2020] FDA published a guidance this week about its on-site inspection policies during the pandemic which all but confirms that it is not planning to conduct any foreign on-site inspections and few, if any, domestic on-site inspections, till at least the rest of the year and possible into the first quarter of next year. FDA will not send inspectors to sites till it is safe for them to travel and the earliest estimates for the pandemic to be under control via a vaccine are not till next year. FDA will continue remote audits via review of documents, and past compliance status of the facility. It could mean that new manufacturing facilities with no history of FDA review, would likely have a higher threshold of clearance to manufacture compared to sites with past approvals. For cause and pre-approval inspections are considered “mission-critical” but even for these, the current FDA policy is to apply a holistic approach based on the totality of information available to FDA from submitted applications and responses to FDA comments from applicants. For imported products, FDA will increase sampling of shipments at the ports of entry. New foreign manufacturing sites will likely get affected the hardest while established facilities, both domestic and foreign, should not see any difference in their interactions with the FDA. Review of all information available from and about a given manufacturer has always been important for FDA’s assessment of the compliance status of a given organization. The pandemic has just pushed this approach to the fore-front as on-site inspections have not been possible. By the time on-site inspections could get to their pre-pandemic frequency, it would have been more than a year of gap in on-site inspections by FDA. One could wonder if these temporary policies may become a permanent feature of FDA’s compliance enforcement practices. After all, if by avoiding the logistics of travel, FDA can multiply its available resources and still do the job, why should FDA stop doing that once the pandemic is over. Good documentation and demonstration of compliance with a holistic approach can help the sponsors too. Overall, these policies help reduce time, cost, and efforts to conduct routine surveillance, allow increased automation, and more resources for preventing the most egregious violations of the law. And that should happens always. |
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