By Category
by this agency in this category 835 findings drawn from 708 published documents. The most recent cases are below; the full set is in search.
See all US FDA Quality unit oversight findingsFailure of your quality unit to exercise its responsibility to ensure the active pharmaceutical ingredient (API) and intermediates manufactured at your facility are in compliance with CGMP.
See every finding in this document View the regulator's official sourceThe responsibilities and procedures applicable to the Quality Unit are not fully followed.
See every finding in this document View the regulator's official sourceThe responsibilities and procedures applicable to the quality control unit are not fully followed.
See every finding in this document View the regulator's official sourceReprocessing was performed without the review and approval of the quality control unit.
See every finding in this document View the regulator's official sourceThe responsibilities and procedures applicable to the quality control unit are not fully followed.
See every finding in this document View the regulator's official sourceThe responsibilities and procedures applicable to the quality control unit are not fully followed.
See every finding in this document View the regulator's official sourceThese findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-10-20, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
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