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Regulatory reporting and change control Findings

in this category 539 findings drawn from 531 published documents. The most recent cases are below; the full set is in search.

See all Regulatory reporting and change control findings

Which agency cited it

Health Canada 462
US FDA 77

Companies with the most findings

Air Liquide Canada Inc.16Voyant Beauty, Inc.9AnazaoHealth Corporation4Kohl & Frisch Limited4Linde Canada Inc.4

Recent findings

US FDA Diagast 2026-10-19

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

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US FDA Apollo Care LLC 2026-09-10

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 5038 because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

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Narrow by agency

Health Canada 462US FDA 77

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.

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