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# FDA Postpones Domestic/Foreign Inspections Indefinitely
- URL: https://www.fdaweb.com/fda-postpones-domestic-foreign-inspections-indefinitely/
- Published: 2020-05-04T12:00:00.000Z
- Updated: 2026-09-14T16:13:34.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146706

FDA’s moratorium on domestic and foreign inspections during the Covid-19 emergency has been extended indefinitely. In [early March](https://www.fdaweb.com/fda-postpones-foreign-inspections-until-may/), FDA first postponed foreign inspection of regulated products until 5/1\. Shortly thereafter, domestic inspections were postponed too. FDA spokesman **Jeremy Kahn** told ***FDA Webview*** 5/4 that the agency is continuing to assess a full return to its inspection capabilities, and “we continue to focus on and accomplish other mission critical activities including import oversight, investigations, and sample collection/analysis where deemed necessary.”

During the moratorium extension, inspections deemed mission-critical will still be considered on a case-by-case basis, Kahn said. “The FDA is leveraging other regulatory tools described by the [commissioner’s statement on foreign inspections](https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreign-inspections?ref=fdaweb.com), to conduct our inspectional work,” he added. “These alternative approaches to on-site inspection have provided FDA with useful information toward fulfilling the agency’s mission, and we will continue to implement this approach until further notice.”

It is uncertain how FDA, once it gives its investigators the green light, will address the inspection backlog for routine and pre-approval inspections and how these will be prioritized. FDA inspection numbers for fiscal year 2020 have taken a big hit since March when foreign and domestic inspections were postponed.

Before the Covid-19 emergency, domestic inspections for all program areas had been averaging about 800 each month in fiscal year 2020, according to FDA enforcement statistics. But in March, the agency recorded just 410 inspections, and in April, only nine, which are presumably “for cause” inspections that the agency said it would conduct on a case-by-case basis. Foreign inspections were averaging 173 per month, dropping to 25 in March and zero in April.

Warning Letters for medical product violations have also been impacted by Covid-19\. Through February, FDA had issued 60 Warning Letters to pharmaceutical manufacturers, 19 to device makers and five to biologic companies — for a monthly average of 15 medical product letters. But in March, those numbers became skewed when CDER began issuing letters to companies over their illegal marketing of products for Covid-19-related uses. For example, in March 24 letters were issued —only two letters each for biologic and device makers, and 20 drug letters that were mainly sent on Covid-19 related matters. In April, those numbers were mainly unchanged, with one issued for biologics, two for devices, and 21 for drugs (mostly Covid-19).

Meanwhile, BakerHostetler attorneys say that in this time of a Covid-19 pandemic, companies should be making specific GMP adjustments. “This includes conducting internal audits of GMP compliance and increased scrutiny in specific areas that may relate to Covid-19,” the company says in an online [post](https://www.bakerlaw.com/alerts/fda-current-good-manufacturing-practice-inspections-during-the-covid-19-pandemic?ref=fdaweb.com).

As an example, it says that companies should consider training their employees on preventing the spread of disease and providing them regular updates on Covid-19 developments. “It may also be necessary to institute stricter protocols for hygiene, employee health, equipment sanitation, and even employee quarantines,” the post says. It also says that during the pandemic agency inspections will likely focus on a facility’s sanitary conditions and the health and hygiene of the facility’s employees. “Pharmaceutical manufacturers, therefore, should thoroughly review policies regarding symptomatic presentations, potential Covid-19 infections, sterilization, and associated reporting,” the post says.