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FDA Extends Halt on Routine Inspections

Denis Storey
June 14, 2020

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On May 11, the FDA announced it would continue to implement alternative inspection tools and approaches while postponing most domestic and foreign routine surveillance inspections.

The FDA also stated in the update that it’s working with the U.S. Centers for Disease Control and Prevention (CDC) on a phased plan to resume onsite surveillance inspections. The policy will govern the return to onsite inspections under the gating criteria outlined in the White House Guidelines for Opening Up America Again.

FDA Pulls Back on In-Person Inspections During COVID-19

On March 10, the FDA announced it was suspending in-person audits in foreign countries until the end of April.

“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” FDA Commissioner of Food and Drugs Dr. Stephen M. Hahn wrote in an announcement about the temporary suspension. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”

A little more than a week later, the agency added it was also suspending routine domestic facility inspections.

“Importantly, during this interim period, we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protects both the firms and the FDA staff,” Hahn said. “This could include, among other things, evaluating records instead of conducting an onsite inspection on an interim basis when travel is not permissible.”

Audits Remain Important

Earl Arnold, manager of Food Defense and FSMA Quality Assurance at AIB International, wrote in a recent Baking & Snack article that “Though the FDA suspended routine food safety inspections, there are two areas audits may be more important than ever. The first is sanitation. The second area of importance is a self-inspection program; this should be more focused on reviewing personnel practices like washing hands.”

Audits assist in many ways, including assessing compliance with standards, regulations, and guidance; adherence to requirements and specifications; evaluating process and system performance; evaluating the adequacy and effectiveness of the quality management system, and confirming conformance with contractual obligations. 

Remote or Virtual Audits Are The Answer

Remote or virtual audits can provide food and supplement makers with an effective alternative to onsite audits to ensure continued compliance with Good Manufacturing Practices (GMPs).

TraceGains can help. Supplier Management provides an automatic risk assessment on raw materials, items, and suppliers to focus resources on your highest risks. The automated collection of documents and data lays the foundation for a virtual audit. Audit Management allows teams to schedule, conduct, and track audits on a single platform using a desktop or mobile device. 

Want to learn more? Request a demo today.