US FDA
Misemer Pharmaceutical, Inc.
2026-07-14
Written procedures have not been developed for the reporting to FDA of post marketing adverse drug experiences.
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Regulatory reporting and change control Findings
in this category 525 findings drawn from 517 published documents. The most recent cases are below; the full set is in search.
See all Regulatory reporting and change control findingsWhich agency cited it
Health Canada
450
US FDA
75
Companies with the most findings
Recent findings
US FDA
Misemer Pharmaceutical, Inc.
2026-07-14
An annual report was not submitted within 60 days of the anniversary date of U.S.
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US FDA
Baxalta US Inc.
2026-07-14
An MDR report was not submitted within 30 days ofreceiving 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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Health Canada
Galderma Canada Inc
2026-07-07
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
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Health Canada
Alchemee Skincare Corporation
2026-06-23
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
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Health Canada
Kingsway Wholesale
2026-06-19
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
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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 2026-09-04, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
