Firm Record
Delta Pharma Inc. findings history
94 findings from 11 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Equipment and facilityStability and storageOther quality systemMaterial and supplier controlDeviation, CAPA, and investigationTraining and personnelCleaning validationAseptic processing and sterility assuranceComplaint and recall handlingLaboratory and QC controlsLabeling and packagingRegulatory reporting and change controlComputer system validationProcess validationContamination controlDocumentation and records
Published inspection documents
2024-05-21
US FDA
3 findingsMaterial and supplier control · Process validation Representative samples are not taken of each shipment of each lot of components for testing or examination .
2024-04-03
Health Canada
7 findingsEquipment and facility · Contamination control · Deviation, CAPA, and investigation · Laboratory and QC controls · Other quality system · Stability and storage The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
2024-04-03
Health Canada
12 findingsDeviation, CAPA, and investigation · Stability and storage · Cleaning validation · Equipment and facility · Contamination control · Other quality system · Regulatory reporting and change control · Material and supplier control The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
2024-01-17
US FDA
9 findingsTraining and personnel · Aseptic processing and sterility assurance · Equipment and facility · Laboratory and QC controls · Process validation · Labeling and packaging · Stability and storage · Documentation and records Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
2024-01-17
US FDA
8 findingsAseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Training and personnel Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
2024-01-17
US FDA
6 findingsEquipment and facility · Stability and storage · Material and supplier control · Labeling and packaging · Aseptic processing and sterility assurance · Laboratory and QC controls Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
2022-09-26
US FDA
5 findingsTraining and personnel · Aseptic processing and sterility assurance · Equipment and facility Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
2022-05-31
Health Canada
7 findingsComputer system validation · Other quality system · Cleaning validation · Training and personnel · Deviation, CAPA, and investigation · Labeling and packaging · Complaint and recall handling The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The establishment and/or the maintenance of a data governance plan was inadequate.
2022-05-31
Health Canada
12 findingsOther quality system · Equipment and facility · Complaint and recall handling · Training and personnel · Labeling and packaging · Stability and storage · Cleaning validation · Computer system validation · Deviation, CAPA, and investigation The sampling, testing, and/or specifications for total microbial count were inadequate.
2021-04-19
Health Canada
11 findingsEquipment and facility · Deviation, CAPA, and investigation · Other quality system · Stability and storage · Complaint and recall handling · Material and supplier control · Regulatory reporting and change control · Cleaning validation The establishment and/or the maintenance of a data governance plan was inadequate.
2021-04-19
Health Canada
14 findingsEquipment and facility · Computer system validation · Material and supplier control · Cleaning validation · Laboratory and QC controls · Other quality system · Complaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The maintenance of personnel records 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.
