More Unannounced Inspections at Foreign Food and Medical Facilities

In a move that the Food and Drug Administration said “marks a new era in FDA enforcement,” the agency has announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. consumers and patients. The FDA states that this change builds on a pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.  

The FDA notes that it conducts about 3,000 inspections each year in more than 90 countries and that foreign facilities are given advance notice of such inspections. While this practice undermines “the integrity of the oversight process,” the FDA states, the agency still “found serious deficiencies [in foreign inspections] more than twice as often than during domestic inspections.”