Firm Record

Baxter Healthcare Corporation findings history

33 findings from 5 inspection documents published by regulators. Each row below says what its date means.

US FDAHealth Canada 2023-08-01 ~ 2026-03-23 5 documents 33 findings

Areas cited

Equipment and facilityOther quality systemAseptic processing and sterility assuranceDeviation, CAPA, and investigationProcess validationContamination controlMaterial and supplier controlQuality unit oversightCleaning validationLaboratory and QC controlsEnvironmental monitoring

Published inspection documents

2026-03-23 Health Canada 6 findingsOther quality system · Contamination control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance The company's visual inspection of filled containers was inadequate. 2025-09-15 Health Canada 14 findingsContamination control · Other quality system · Aseptic processing and sterility assurance · Cleaning validation · Equipment and facility · Environmental monitoring · Laboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. 2024-01-17 US FDA 4 findingsOther quality system · Equipment and facility · Process validation · Quality unit oversight Products that do not conform to specifications are not adequately controlled. 2024-01-17 US FDA 5 findingsQuality unit oversight · Equipment and facility · Material and supplier control · Process validation The quality control unit lacks responsibility to approve all procedures or specifications impacting on the quality and purity of drug products. 2023-08-01 US FDA 4 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Equipment used in the manufacture of terminally sterilized drugs at your facility is not designed or maintained appropriately. Our inspection revealed instances of damaged metal and plastic parts, open vials…

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 Baxter Healthcare Corporation — including inspection classifications Browse by document Go to Findings search