Firm Record
Hospira Inc. findings history
95 findings from 8 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Process validationOther quality systemAseptic processing and sterility assuranceEquipment and facilityDeviation, CAPA, and investigationQuality unit oversightLaboratory and QC controlsContamination controlMaterial and supplier controlTraining and personnelComplaint and recall handlingDocumentation and recordsStability and storageComputer system validation
Published inspection documents
2026-07-10
US FDA
6 findingsQuality unit oversight · Process validation · Equipment and facility · Other quality system Your firm faited to establish adequate quality control unit oversight with the responsibility and authority to approve or reject production and quality documents.
2024-01-17
US FDA
19 findingsEquipment and facility · Material and supplier control · Laboratory and QC controls · Complaint and recall handling · Process validation · Aseptic processing and sterility assurance · Other quality system · Training and personnel · Stability and storage Buildings used in the manufacturing, processing, packing, and holding ofa drug product are not maintained in a good state of repair.
2024-01-17
US FDA
6 findingsLaboratory and QC controls · Process validation · Complaint and recall handling · Equipment and facility The written stability program for drug products does not include meaningful test methods.
2024-01-17
US FDA
20 findingsTraining and personnel · Aseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Laboratory and QC controls · Deviation, CAPA, and investigation · Process validation · Quality unit oversight · Other quality system Employees engaged in the manufacture and processing of a drug prodoct lack the training required to perform their assigned functions.
2024-01-17
US FDA
18 findingsDeviation, CAPA, and investigation · Other quality system · Process validation · Equipment and facility · Quality unit oversight · Stability and storage · Training and personnel · Contamination control · Complaint and recall handling Investigations ofan unexplained discrepancy and a failure ofa batch or any of its components to meet any ofits specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
2021-11-08
Health Canada
8 findingsContamination control · Laboratory and QC controls · Aseptic processing and sterility assurance · Other quality system · Computer system validation · Deviation, CAPA, and investigation The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
2021-05-24
US FDA
9 findingsQuality unit oversight · Contamination control · Documentation and records · Deviation, CAPA, and investigation · Material and supplier control · Process validation · Aseptic processing and sterility assurance The responsibilities and procedures applicable to the quality control unit are not fully followed.
2021-05-05
US FDA
9 findingsAseptic processing and sterility assurance · Documentation and records · Process validation · Quality unit oversight · Deviation, CAPA, and investigation · Contamination control · Material and supplier control Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
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.
