Warning Letter — SCA Pharmaceuticals, LLC
The FDA issued a Warning Letter to SCA Pharmaceuticals, LLC on September 14, 2026, following an inspection by the Center for Drug Evaluation and Research (CDER).
This action affects SCA Pharmaceuticals, LLC, as well as personnel involved in sterile drug manufacturing, quality control, and regulatory compliance at the facility.
A Warning Letter from CDER indicates significant deviations from regulatory requirements that could impact the safety or quality of drug products. For the affected firm, this likely necessitates comprehensive remediation of manufacturing processes and quality systems to prevent potential product contamination or further regulatory escalation.
Quality units should review sterile manufacturing protocols and contamination control strategies to ensure alignment with current Good Manufacturing Practice (cGMP) standards. Conduct internal audits focused on environmental monitoring and aseptic processing validation to identify potential compliance gaps.
FDA Warning Letter issued to: SCA Pharmaceuticals, LLC. 09/14/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sca-pharmaceuticals-llc-724202-09142026
Open in openFDA / FDA.gov