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# Baxter Oncology FDA-483 Out
- URL: https://www.fdaweb.com/baxter-oncology-fda-483-out/
- Published: 2025-11-06T12:00:00.000Z
- Updated: 2026-09-14T15:26:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160171

FDA has released the form FDA-483 issued following an 8/19-8/27 inspection at the Baxter Oncology drug manufacturing facility in Halle, Westfalen, Germany. The inspection observations were:

- failure to establish process, procedural controls, and testing designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to have available calibrations to a specification in support of a redacted drug product;
- the redacted drug substance storage requirement is unclear;
- a validation in support of a redacted drug product is deficient;
- standard operating procedures supporting the manufacture of a redacted drug product are deficient or not followed; and
- failure to adequately maintain facilities and equipment in support of a redacted drug product.