Issued to Jubilant HollisterStier General Partnership. Serious post-market compliance violation.
Issued
May 28, 2026Product
CGMP/Finished Pharmaceuticals/Adulterated
Company
Jubilant HollisterStier General Partnership
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Jubilant HollisterStier General Partnership concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on May 28, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.