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in this category 2,067 findings drawn from 1,533 published documents. The most recent cases are below; the full set is in search.
See all Laboratory and QC controls findingsLaboratory records do not include a description of the sample received for testing, the lot number or other distinctive code of the sample and the date the sample was received for testing.
See every finding in this document View the regulator's official sourceLaboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
See every finding in this document View the regulator's official sourceFailure to retain sufficient quantities of reserve sample to conduct analyses.
See every finding in this document View the regulator's official sourceYour firm failed to use validated and stability-indicating test procedures.
See every finding in this document View the regulator's official sourceFailure to maintain donor, quality control and general records.
View the regulator's official sourceProcess Control] Procedures that describe any process controls necessary to ensure conformance to the specifications have not been adequately established.
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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