By Agency
by this agency 13,583 findings drawn from 2,990 published documents. The most recent cases are below; the full set is in search.
See all US FDA 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 sourceFailure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.
See every finding in this document View the regulator's official sourceFailure to monitor thebe system to ensure that water is of appropriate quality.
See every finding in this document View the regulator's official sourceFailure to ensure that all specifications are scientifically sound and appropriate to ensure that your raw materials and API conform to established standards of quality and purity.
See every finding in this document View the regulator's official sourceFailure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API.
See every finding in this document View the regulator's official sourceYour firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of data.
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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