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# Three Possible Foreign Inspection Outcomes Seen
- URL: https://www.fdaweb.com/three-possible-foreign-inspection-outcomes-seen/
- Published: 2020-07-16T12:00:00.000Z
- Updated: 2026-09-14T16:21:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147210

Attorney **Mark Schwartz** (Hyman, Phelps & McNamara) says that with the planned FDA resumption of domestic inspections, there are three likely scenarios involving the still-paused foreign inspections. Writing in his firm’s *FDA Law Blog*, Schwartz [says](http://www.fdalawblog.net/2020/07/12030/?ref=fdaweb.com) that either on-site foreign inspections will resume, FDA will loosen an overly restrictive interpretation of a section of the Federal Food, Drug, and Cosmetic Act (FFDCA) relating to “record review,” or there will be a worsening of America’s drug shortage and a slowing of the availability of new drugs.

The question of foreign inspections is important, he says, because the bulk of inspection sites, particularly for drugs and biologics, are outside the U.S., and that’s where the major backlog is.

The attorney says that based on the principles FDA outlined for resuming domestic inspections, the agency should be able to restart foreign inspections soon. “In countries where the testing is widespread and reliable, where epidemiological information from such governments can be trusted, and where the data shows an analogous concentration of Covid-19 cases as what is considered acceptable for domestic inspections, FDA should be able to resume on-site foreign inspections,” he writes. However, Schwartz also notes that inspectors will have to get to their destinations, with the foreign governments being willing to allow entry of Americans into their countries.

“Failing a resumption of foreign on-site inspections soon, it is unclear what FDA’s plan is to resolve the existing backlog, and that is presumably worsening by the week,” he writes.

Schwartz says the agency appears to be unwilling or unable to use its statutory authority to conduct “record review” to resolve the official action indicated (OAI) status at facilities that were designated in that way by FDA before inspections were paused. He says that agency officials have been quoted as saying that if FDA is not on-site at a manufacturing facility, then whatever remote FDA facility review takes place cannot be an inspection for purposes of the FFDCA and therefore presumably cannot resolve a firm’s OAI status.

“Arguably,” Schwartz concludes, “if FDA had maintained such a restrictive construction of the FFDCA over the 80 years since its enactment, the agency would have had to abandon some of the authority it currently exercises and takes for granted.”