Warning Letter — Safrel Pharmaceuticals LLC
The FDA issued a Warning Letter to Safrel Pharmaceuticals LLC following an evaluation by the Center for Drug Evaluation and Research (CDER).
This notice affects Safrel Pharmaceuticals LLC, its manufacturing facilities, and personnel responsible for quality oversight and regulatory compliance.
A Warning Letter from CDER indicates that the FDA has identified significant violations of CGMP regulations. This suggests that the firm's quality systems may be insufficient, potentially leading to regulatory hold-ups, import alerts, or the need for extensive remediation to maintain market standing.
Conduct a comprehensive audit of Current Good Manufacturing Practice (CGMP) compliance; evaluate the adequacy of quality control systems and oversight of manufacturing processes to ensure alignment with FDA expectations.
FDA Warning Letter issued to: Safrel Pharmaceuticals LLC. 08/07/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safrel-pharmaceuticals-llc-730520-08072026
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