By Country
at manufacturing sites in this country 8,433 findings drawn from 1,369 published documents. The most recent cases are below; the full set is in search.
See all United States findingsThe batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing and packing.
See every finding in this document View the regulator's official sourceWritten records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
See every finding in this document View the regulator's official sourceProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
See every finding in this document View the regulator's official sourceDrug product (b) (4) are (b) (4) so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
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 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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