Warning Letter — Silgan Dispensing Systems
The FDA issued a Warning Letter to Silgan Dispensing Systems on October 5, 2026, following a review by the Center for Drug Evaluation and Research (CDER).
Silgan Dispensing Systems, as well as pharmaceutical manufacturers and quality departments utilizing their dispensing components for drug delivery products.
Issuance of a formal Warning Letter from CDER indicates significant deviations from regulatory requirements that could potentially impact the supply chain for drug products utilizing these dispensing systems. Regulatory teams may need to evaluate the impact on their own drug applications or quality management systems depending on the specific violations, which are not detailed in the provided excerpt.
Conduct an immediate audit of dispensing system manufacturing protocols and quality control documentation to ensure alignment with CDER expectations. Review existing supplier agreements and technical files for compliance with current good manufacturing practices.
FDA Warning Letter issued to: Silgan Dispensing Systems. 10/05/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/silgan-dispensing-systems-734538-10052026
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