Inspection Record

CSL Behring GmbH — FDA 483 Findings

US FDAInspected 2026-02-18Published 2026-07-22 5 findingsEquipment and facilityComplaint and recall handlingQuality unit oversightDeviation, CAPA, and investigation

Inspectors Travis S Bradley · Burnell M HenryThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

2Complaint and recall handling

Procedures describing the handling of all written and oral complaints regarding a drug product are not established and followed.

3Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

4Quality unit oversight

Changes to written procedures are not reviewed and approved by the quality control unit.

5Deviation, CAPA, and investigation

Failure to submit biological deviation.

About this record

Extracted automatically from the document US FDA published on 2026-07-22. 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.

CSL Behring GmbH company profile — full history US FDA documents, 2026 Go to Findings search