Novo gets FDA warning letter at troubled Indiana site formerly owned by Catalent - Fierce Pharma
FDA issued a warning letter to Novo Nordisk's Indiana site (formerly Catalent), indicating cGMP compliance issues that could affect drug supply and approvals.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on August 9, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, and compounding outsourcing (503B) facilities that rely on this site or similar operations. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Not specified in the change text.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA issued a warning letter to the Indiana site, signaling potential cGMP violations that may lead to import alerts, consent decrees, or shutdowns.
Who it affects
Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, and compounding outsourcing (503B) facilities that rely on this site or similar operations.
What you must do
Review supply chain dependencies on this site; assess alternative suppliers; ensure own facilities comply with cGMP to avoid similar actions.
Deadline
Not specified in the change text.
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