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Volume X, Number 221

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FDA Announces Plans to Resume Domestic On-site Inspections

On July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20.  The Agency has developed a “COVID-19 Advisory Level” risk-based rating system to help assess where inspections may safely resume.  Under the rating system, facilities in areas where cases of COVID-19 are under control can expect to be inspected sooner than facilities in areas where COVID-19 cases are on the rise.

How will FDA prioritize where to resume inspections?

FDA developed a rating system, called the COVID-19 Advisory Level, which is based on three metrics: (1) Phase of the State (defined by the White House guidelines); (2) county-level statistics; and (3) intensity of infection. With these metrics in mind, FDA will then identify regulatory activities that may occur within a given geographic region.

Regulatory activities that may resume at the local level, based on the outcome of the rating, may be: (i) mission critical inspections only; (ii) all inspections, with caveats to help protect staff who have self-identified as being in a vulnerable population; or (iii) resumption of all regulatory activities.

FDA reports that resuming domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments.  The Agency also acknowledges that its ability to resume inspections will be affected by other services affected by the pandemic, such as public transportation.

Will FDA publish COVID-19 Advisory Level information?

COVID-19 Advisory Level data will be made available to state partners who, under contract, conduct inspections of FDA-regulated entities on the agency’s behalf.  The Agency’s announcement did not state that COVID-19 Advisory Level would otherwise be made publicly available.

Will FDA announce domestic inspections ahead of time?

Yes, except for retail tobacco operations.  For the “foreseeable future,” domestic inspections will be pre-announced to the business, with the exception of retail tobacco inspections.

What about foreign inspections?  

Foreign inspections are not addressed in the announcement.  FDA’s most recent statement on foreign inspections on May 11, 2020, announced that the Agency would continue to postpone foreign inspections because of COVID-19 concerns.  FDA’s May announcement was an extension of its initial suspension announced on March 10 and 18.  An FAQ on FDA inspections during COVID-19 can be found here.

To read more about FDA actions to address COVID-19, click here.

Copyright © 2020, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume X, Number 195

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About this Author

Allison Fulton DC SheppardMullin Shareholder Life Sciences FDA
Shareholder

Allison Fulton is a partner in the Life Sciences and FDA team and is based in the firm's Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

Areas of Practice

Allison’s areas of focus include assisting U.S. and international companies comply with current Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR). She regularly advises...

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Julia Kadish is an attorney in the Intellectual Property Practice Group in the firm's Chicago office.

Areas of Practice

Julia's practice focuses on data breach response and preparedness, reviewing clients' products and services for privacy implications, drafting online terms and conditions and privacy policies, and advising clients on cross-border data transfers and compliance with US and international privacy regulations and standards. She also workes on drafting and negotiating software licenses, data security exhibits, big data licenses, professional services agreements, and other commercial agreements involving technology. Julia advises on strategic and operational decisions involved with conducting internal investigations in response to government investigations or for purposes of corporate compliance.

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