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Volume X, Number 221

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Get Ready for FDA On-Site Inspections

After a four-month hiatus in which it suspended inspection activities because of the coronavirus pandemic,  the United States Food and Drug Administration (FDA)  announced on July 10, 2020, that it will resume on-site inspections of regulated facilities. The FDA had previously announced on March 10 that routine domestic inspections would be put on hold to protect the health of its inspectors. 

Advance notice of the inspections will be provided for now. The only exception will be for retail tobacco sites because those inspections are typically undercover operations where the retailer is unaware that an inspection is taking place. 

Inspections will begin the week of July 20. The FDA will resume inspections in accordance with the White House Guidelines for Opening Up America Again, which means that inspections will resume only in geographic areas where COVID-19 infection rates and hospitalizations are declining. The FDA has developed a rating system to determine when and where domestic inspections can be conducted safely. The three-part rating system will indicate whether to conduct only mission-critical inspections, conduct all inspections with safeguards to protect staff that have self-identified as being part of a vulnerable population, or resume all normal regulatory activities in a given geographic area. 

Despite the pause of routine inspections in March, FDA inspectors have continued to conduct mission-critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA guidelines. In addition, the FDA has issued a constant stream of warning letters to companies engaged in conduct that appears to violate FDA guidelines or the federal Food, Drug, and Cosmetic Act (FDCA) – with a notable focus on companies making health claims about the ability of their product to diagnose or treat health conditions, including COVID-19. 

Inspections of Foreign Facilities

Meanwhile, FDA inspections of foreign facilities have not resumed. Some foreign groups have requested that the FDA consider virtual inspections for new facilities, facilities that plan to produce a new class of drugs and facilities that have created a corrective action following an inspection failure. The FDA has noted that it found the proposals “useful,” but it has not yet committed to conducting virtual inspections. 

Now is an excellent time for companies to ensure that they are prepared for an FDA inspection. 

© 2020 Wilson ElserNational Law Review, Volume X, Number 197


About this Author

Amy L. Baker, Wilson Elser, Products Liability Lawyer, Medical Device Attorney,

Amy Baker focuses her practice on product liability, medical device and pharmaceuticals litigation, and professional malpractice. She has experience in defending and prosecuting intellectual property litigation, including copyright, patent and trademark infringement along with related causes of action under state law.  Amy enjoys handling technically challenging and complex litigation, and defending matters that are factually and procedurally intricate. Amy has successfully tried several cases to verdict on behalf of a variety of companies. She has experience defending...