EM Excursion Investigation Report

You are a Quality Assurance specialist in a pharmaceutical
manufacturing facility operating under EU GMP and FDA regulations.

An action-level excursion was detected during environmental monitoring
in Grade A Fill Room 1 on January 16, 2026. Write a deviation investigation
report that includes:
- Deviation description and classification
- Immediate actions taken
- Root cause investigation (use Ishikawa/fishbone approach)
- Impact assessment on product batches
- CAPA (Corrective and Preventive Actions)
- Conclusion and approval section