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# 4 Observations in Behring German Facility Inspection
- URL: https://www.fdaweb.com/4-observations-in-behring-german-facility-inspection/
- Published: 2026-07-23T12:00:00.000Z
- Updated: 2026-09-14T13:43:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161510

FDA has released the form FDA-483 issued following a 2/9-2/18 inspection at the CSL Behring GmbH licensed biological drug manufacturing facility in Marburg, Hassia, Germany. The four inspection observations were:

- failure of the quality control unit to review and approve changes to written procedures;
- failure to submit biological deviation;
- failure to establish and follow procedures describing the handling of all written and oral complaints about a drug product; and
- failure to clean equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product.