Warning Letter — Curia New York, Inc.
The FDA issued a Warning Letter to Curia New York, Inc. following an inspection by the Center for Drug Evaluation and Research (CDER). The letter documents specific violations of Current Good Manufacturing Practice (cGMP) regulations.
This affects Curia New York, Inc., its contract manufacturing partners, and pharmaceutical companies utilizing this facility for drug product or active pharmaceutical ingredient production.
The issuance of a Warning Letter by CDER indicates that the facility's manufacturing or quality control processes failed to meet regulatory standards. This suggests potential risks to product quality and may lead to regulatory delays for new drug applications or supplements associated with this site. Operational teams may face increased scrutiny during follow-up inspections.
Review site-specific Quality Agreements and audit recent batch records for compliance with Current Good Manufacturing Practice (cGMP) standards. Ensure that any identified deficiencies in the facility's manufacturing processes are addressed through a formal Corrective and Preventive Action (CAPA) plan.
FDA Warning Letter issued to: Curia New York, Inc.. 09/18/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curia-new-york-inc-728790-09182026
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