Warning Letter — Jubilant HollisterStier General Partnership
The FDA issued a Warning Letter to Jubilant HollisterStier General Partnership following an inspection by the Center for Drug Evaluation and Research (CDER).
This affects Jubilant HollisterStier General Partnership and its drug manufacturing operations, specifically personnel involved in quality management and production compliance.
A Warning Letter signifies that the FDA has identified significant violations of CGMP regulations. This may lead to the withholding of new drug approvals or the restriction of export certificates for the site until the deficiencies are corrected and verified by the agency. The source does not specify the exact nature of the violations, but such actions typically require rigorous remediation to avoid further enforcement.
Regulatory and QA teams should conduct a comprehensive review of current manufacturing workflows to identify potential CGMP gaps. Ensure that any cited deficiencies are addressed through a robust CAPA plan that includes verifiable remediation steps prior to further agency interaction.
FDA Warning Letter issued to: Jubilant HollisterStier General Partnership. 05/28/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jubilant-hollisterstier-general-partnership-723537-05282026
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