Coronavirus Disrupting Supplier Audits in FDA-Regulated Manufacturing: Get Local Resources Now

Widespread travel restrictions prompted by the global coronavirus (COVID-19) outbreak have begun to impact critical operations across life science manufacturing, including supplier audits.

There is now evidence on six continents of sustained transmission, and the CDC has advised against all non-essential travel throughout most of Europe, and to South Korea, China and Iran. Older and at-risk Americans have been warned to avoid travel to any country.

In particular, these restrictions have impeded external auditors seeking entry into affected countries, potentially delaying scheduled audits and complicating the export of critical pharmaceutical, device, and diagnostic products exactly when they're needed most.

While regulators like the FDA are putting significant measures in place to do everything possible to prevent delays and shortages, the delay of a critical supplier audit can create a cascade of other issues that impact timelines and product availability. 

If you are looking for localized auditors in areas affected by these restrictions, we can help. We have local auditors in every inhabitable continent ready to assist. Contact us by phone or online today to get access to these local auditing resources where and when you need them:

US Toll-Free: 1-833-FDA-GROUP
International: +001 508 926 8330
Email: info@thefdagroup.com

Roundup: Coronavirus (COVID-19) and Its Impact on Life Science Manufacturers

• Travel restrictions are already delaying major life science manufacturing projects abroad. Celltrion, a company located in the Republic of Korea told the Center for Biosimilars it would delay the construction of a $514 million plant for the manufacture of biologics, including biosimilars, in Wuhan, China. Celltrion evacuated its employees and announced it would manage construction of the plant from afar until the outbreak resolves.
• On March 11, India announced its intention to stop issuing most visas for travel until mid-April. The country said it would quarantine all incoming travelers, including Indian nationals, arriving from China, Italy, Iran, Republic of Korea, France, Spain, and Germany.
• Other nations across the world have imposed travel restriction to curb the spread of the virus. See the current list of countries limiting entry here, via The New York Times.
• The supply of drug APIs in the United States is largely reliant on foreign manufacturing, highlighting the pressure on taking rapid action. As shown in FDA data, a total of 1079 facilities worldwide that make the 370 drugs on the World Health Organization‘s Essential Medicines List that are marketed in the United States. Only 21% of those facilities are based in the United States.
• On March 10, the FDA announced that it was suspending foreign site inspections and shifting to remote monitoring in an effort to protect the health of its staff. The agency noted that inspections would occur through remote means, such as data review, or at US ports of entry, wherever product flows in. Need help preparing for a remote FDA inspection? Contact us today.

Get Access to Local Auditors Around the World

The FDA Group has 600+ specialists worldwide, many of whom are located in areas affected by recent travel restrictions. If you are looking for localized auditors in areas affected by these restrictions, we can help. We have local auditors in every inhabitable continent ready to assist. Contact us by phone or online today to get access to these local auditing resources where and when you need them.

US Toll-Free: 1-833-FDA-GROUP
International: +001 508 926 8330
Email: info@thefdagroup.com