1Validation and qualification
A validation in support ofl6>l 4> rug product manufacture is deficient.
Inspection Record
Baxter Oncology GmbH — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Calibrations to a specification in support ol6>(..f) rug product manufacture are not available.
3Other quality system
Standard operating procedures (SOP) supporting manufacture o rug product are deficient or are not followed.
4Other quality system
J:~ilure to establish process, procedural controls and testing ~signed to assure that the drug products you ma1iufacture have the identity, strength, quality and purity that it purports or is represented to possess.
5Stability and storage
Thelfi)l ..f) rug substance (DS) storage requirement is unclear.
About this record
Extracted automatically from the document US FDA published on 2025-11-05. The source is available at the link above.
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.
Translation and classification are automated and may differ in nuance from the source.
