US FDA
Almon Healthcare Private Limited
2026-10-19
Failure to monitor thebe system to ensure that water is of appropriate quality.
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Other quality system Findings
in this category 3,620 findings drawn from 2,090 published documents. The most recent cases are below; the full set is in search.
See all Other quality system findingsWhich agency cited it
Health Canada
2,489
US FDA
1,128
EMA (Europe)
3
Companies with the most findings
Recent findings
US FDA
Johns Hopkins Hospital
2026-10-19
Records including signature by the physician requesting the procedure are not maintained of all emergency transfusions.
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US FDA
GPC Medical Limited
2026-10-19
Procedures for acceptance ofin-process product have not been adequately established.
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US FDA
GPC Medical Limited
2026-10-19
Procedures for Corrective and Preventive Action have not been adequately established.
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US FDA
GPC Medical Limited
2026-10-19
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated.
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US FDA
Dendreon Pharmaceuticals LLC
2026-10-19
Drug 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.
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Other categories
Aseptic processing and sterility assuranceOther quality systemEquipment and facilityLaboratory and QC controlsDeviation, CAPA, and investigationStability and storageMaterial and supplier controlQuality unit oversightComplaint and recall handlingContamination controlLabeling and packagingComputer system validationTraining and personnelProcess validationRegulatory reporting and change controlDocumentation and recordsCleaning validationValidation and qualificationEnvironmental monitoringData integrity
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 2026-10-20, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
