FDA: more unannounced Inspections also outside the US

The US Food and Drug Administration (FDA) has announced a major change in how it inspects foreign manufacturing sites that make food, medicine, and other medical products for American consumers. From now on, more foreign inspections could happen without prior warning - just like FDA does in the US This decision builds on a pilot program the FDA tested in India and China.

"For too long, foreign companies have enjoyed a double standard-given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning.," said FDA Commissioner Dr. Martin Makary. "That ends today."

The FDA is also reviewing its policies to strengthen oversight and avoid conflicts of interest. For example, inspectors will no longer accept travel help, like hotel stays or rides, from the companies they're inspecting.

Each year, the FDA conducts approximately 12,000 inspections in the US and 3,000 abroad, covering more than 90 countries. Domestic inspections are generally unannounced. Only in certain programmes and cases are FDA's domestic inspections announced in advance to ensure that appropriate documentation and personnel are available during the inspection. However, companies cannot negotiate the day (or time) of the inspection.

Foreign companies are usually notified in advance - giving them time to prepare and potentially hide problems. Despite this notice, however, the FDA still finds more serious problems outside the US than domestically.

By increasing unannounced inspections, the FDA aims to catch problems early, prevent fraud, and keep unsafe products out of the US. The agency can take action against any company that refuses entry or tries to delay an inspection.

In this context and as a basis for this, US President Trump issued a decree ('REGULATORY RELIEF TO PROMOTE DOMESTIC PRODUCTION OF CRITICAL MEDICINES') to relieve the burden on manufacturers in the USA and ultimately increase the number of inspections abroad. For example, the FDA should develop and promote improvements to the risk-based inspection system for foreign production facilities, funded by increased fees for foreign production facilities. In addition, the FDA must disclose the annual number of foreign inspections by country and manufacturer.