Make abortion pill manufacturer inspections transparent

Research notes

• The Mifepristone Shared System REMS was read directly at REMS@FDA. accessdata.fda.gov opened for us even though fda.gov and the rest of HHS’s sites did not, which is how this cluster was settled without a web search.
• The REMS update history shows exactly five modifications since 2019 and one inside the window (2025-09-30, “Modified to add ANDA 216616”).
• Read 2026-09-06. fda.gov now opens; the earlier failures came from how the pages were requested and from a retired path (the inspection search at accessdata.fda.gov/scripts/inspsearch/ is gone). The warning-letters database (fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters, 3,677 letters, 2021–2026) returns no letter to Danco or to GenBioPro. The inspection classification database now lives at datadashboard.fda.gov/oii/cd/inspections.htm, a dashboard whose data can be queried only with a registered key; its in-page search did not filter on either name in this read, and its dataset is a download. None of that bears on the Status: the Quote asks for a policy of transparency about these sponsors’ inspections, and no such policy has been issued — a database entry, present or absent, is not one. It stays not started; the dataset download is the only open route we found to the inspection record itself.