FDA 483 Issued to Novo Nordisk’s Bloomington Site and Key Takeaways
The recent FDA 483 issued to Novo Nordisk’s Bloomington site highlights systemic gaps in contamination control, deviation management & root cause ownership. Key Takeaways for GxP professionals:1. Recurring mammalian hair contamination was observed across multiple batches for nearly three years without a validated root cause, even post-acquisition and recall activities. 2. Cleanroom water ingress led…
