> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Grassley Wants Unannounced Foreign Drug Inspections
- URL: https://www.fdaweb.com/grassley-wants-unannounced-foreign-drug-inspections/
- Published: 2019-08-07T12:00:00.000Z
- Updated: 2026-09-15T01:42:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144711

Senate Finance Committee chairman **Chuck Grassley** (R-IA) says FDA should reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries in light of the administration’s proposed Safe Importation Action Plan and the fact that the foreign facilities provide most of the ingredients for drug production in the U.S. In an 8/7 [letter](https://www.finance.senate.gov/imo/media/doc/2019-08-06%20CEG%20to%20HHS%20FDA%20%28Importation%20Plan%29.pdf?ref=fdaweb.com) to FDA and HHS, Grassley says it is “important to determine more accurately if these facilities meet set standards of quality and safety for both domestic and importation purposes.”

He says news reports and the Government Accountability Office have indicated that last year FDA only inspected one in five registered human drug manufacturing facilities abroad. He also says he has learned that FDA does not track in its databases whether a foreign inspection was subject to an announced or unannounced visit.

“Further,” he writes, “I have learned that FDA generally does not perform unannounced visits of drug manufacturing facilities in foreign countries but does perform unannounced visits here in the United States. Should the Safe Importation Action Plan be put into effect, the administration must require more foreign inspections generally and unannounced inspections specifically, particularly compared to previous administrations.”

The letter says FDA created a 2013 pilot program in India that eliminated advance notice and instead used short notice or unannounced visits. The pilot was shut down in 2015, he says, without explanation. “It is unclear why the Obama administration shut the pilot program down in light of its apparent success,” Grassley concludes. “However, because of its repeated successes, I strongly encourage the administration’s demonstration projects to include unannounced inspections in foreign manufacturing facilities to determine whether they meet the required API and drug quality and safety standards to include sufficient record-keeping, testing, and protections against counterfeiting.”