Firm Record

Eurofins CDMO Alphora Incorporated findings history

51 findings from 8 inspection documents published by regulators. Each row below says what its date means.

Health Canada 2022-05-05 ~ 2025-11-03 8 documents 51 findings

Areas cited

Laboratory and QC controlsComputer system validationOther quality systemStability and storageDeviation, CAPA, and investigationEquipment and facilityCleaning validationRegulatory reporting and change controlComplaint and recall handlingContamination controlMaterial and supplier control

Published inspection documents

2025-11-03 Health Canada 4 findingsOther quality system · Cleaning validation · Stability and storage · Computer system validation The assessment to release finished products was inadequate. 2025-11-03 Health Canada 3 findingsComputer system validation · Laboratory and QC controls · Deviation, CAPA, and investigation The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. 2025-11-03 Health Canada 7 findingsCleaning validation · Deviation, CAPA, and investigation · Computer system validation · Other quality system · Laboratory and QC controls · Stability and storage The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The monitoring procedures for microbial and/or environmental conditions were inadequate. 2024-10-22 Health Canada 3 findingsMaterial and supplier control · Cleaning validation · Stability and storage The standard operating procedures or records for shipping and receiving raw materials were inadequate. 2023-12-11 Health Canada 7 findingsOther quality system · Laboratory and QC controls · Equipment and facility The availability or the content of the authentic certificate of analysis was inadequate. 2023-03-15 Health Canada 5 findingsLaboratory and QC controls · Equipment and facility · Computer system validation The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were inadequate. 2022-05-05 Health Canada 13 findingsEquipment and facility · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Stability and storage · Complaint and recall handling · Regulatory reporting and change control · Contamination control · Computer system validation The maintenance and/or monitoring of the ventilation system's air quality was inadequate. The maintenance of the premises was inadequate. 2022-05-05 Health Canada 9 findingsComputer system validation · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls · Other quality system · Complaint and recall handling The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

About this page

This is a record of that moment. 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 it as the current state; check the regulator's official announcements for the latest status.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Eurofins CDMO Alphora Incorporated — including inspection classifications Browse by document Go to Findings search