The Baxter Global Product and Distribution Surveillance (GPDS) organization is responsible for capturing, processing, evaluating, and investigating product quality (non-medical) post market product complaints for all BioScience manufactured and/or distributed products globally.
If during the investigation confirmed quality issues are identified, Baxter has systems in place to address these issues. Depending on the nature and severity of the issue, the Exception Report (ER), Biological Product Deviation Report (BPDR), or a Field Corrective Action FCA processes may be enacted to address and communicate the issue.
The GPDS team collaborates closely with the manufacturing facilities in conducting root cause investigations. The following illustration describes the workflow for the complaint investigation process:
Ready-to-use 10% sterile, liquid preparation
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Sterile, stable, lyophilized preparation of purified alpha 1-proteinase inhibitor
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A comprehensive portfolio of Ig products for all treatment settings - hospital, outpatient, clinic, and home.
Please consult your local approved product labeling for prescribing information. Please note that not all products are licensed in all countries.