You did not follow written quality assurance procedures.
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Other quality system Findings
in this category 3,539 findings drawn from 2,032 published documents. The most recent cases are below; the full set is in search.
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Procedures describing the warehousing ofdrug products are not established and followed.
See every finding in this document View official sourceYou did not establish product specifications for identity.
See every finding in this document View official sourceProcedures for design change have not been established.
See every finding in this document View official sourceProcedures for corrective and preventive action have not been adequately established.
See every finding in this document View official sourceA correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.
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These 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 2026-09-04, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
