FDA Halts Routine Foreign, Domestic Inspections

Posted by Denis Storey on March 20, 2020 at 12:00 PM

FDA Halts Foreign, Domestic InspectionsAs the number of global COVID-19 deaths surpassed 11,000 this week—with more than a quarter of a million infected worldwide—it’s become increasingly clear the effects of this pandemic will linger for months, if not years.

USA Today reported that “a supply management survey found that three out of every four American businesses experienced a disruption to some part of their supply line due to the irregularities in the shipping industry stemming from the coronavirus pandemic.”

The spread of this virus has hampered regulatory efforts in the food and beverage space as well. On March 10, the U.S. Food and Drug Administration announced it was suspending in-person audits in foreign countries at least 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.”

Now, a little more than a week later, the agency has added it’s 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 about this latest decision. “This could include, among other things, evaluating records instead of conducting an onsite inspection on an interim basis when travel is not permissible.”

This comes at a time when a recent Consumer Brands Association survey found that “food and beverage products remain the No. 1 thing consumers worried they wouldn’t have access to (78%).”

“Within this announcement, the FDA staff reminds industry that following GMPs and regulatory inspections should not be the driver for responsible companies to remain compliant during this unusual time in U.S. history,” United Natural Products Alliance VP-Global Compliance & Regulatory Larisa Pavlick explained. “The FDA staff asks companies to operate with integrity and reminds the industry that only a fraction of companies are audited every year, and compliance and ensuring public health and safety is, and has always been, a shared responsibility between the regulatory bodies and ethical industry.”

“Going forward, the FDA staff will utilize new approaches and tools to ensure public health and safety,” she added. “These new approaches may include techniques recommended under the Food Safety Modernization Act (FSMA), including records review.”

The additional economic impact from COVID-19 includes:

  • The Dow Jones Industrial Average has lost 30% of its value since its February peak of over 29,000.
  • In the United States, 281,000 people filed for unemployment benefits between March 8 and March 14, according to the latest Department of Labor data.
  • The pandemic has cost the worldwide shipping industry roughly $350 million every week, according to the International Chamber of Shipping. Additionally, USA Today also reported that North American shipping traffic fell by nearly 10% in January.
  • Nearly 70% of restaurants reported a traffic decline because of the coronavirus pandemic, according to a recent Black Box Intelligence survey.
  • More than 600 foodservice industry jobs have already disappeared, and the analysts at Challenger, Gray and Christmas claim that 7.4 million jobs in the sector could either be lost or severely affected.
  • Starbucks, typically immune to economic headwinds, reported a 78% drop in same-store sales in February from the year before.

TraceGains has been helping our customers navigate this difficult time, especially helping them find alternate suppliers for key ingredients. Last month, TraceGains CEO Gary Nowacki spoke with United Natural Products Alliance President Loren Israelsen in a webinar covering what supplement manufacturers can do to protect their supply chains. That recording can be found here.

Tags: FDA, audits, COVID-19, coronavirus