SILGAN DISPENSING SYSTEMS CORP – FDA Warning Letter, Apr 2, 2026

On October 5, 2026, the FDA issued a Warning Letter to Silgan Dispensing Systems following an inspection of its Silgan Unicep Packaging, LLC facility in Spokane, Washington, conducted from March 26 to April 2, 2026. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations and the Federal Food, Drug, and Cosmetic Act, rendering the firm"s drug products adulterated.

Primary violations included the failure to adequately investigate out-of-specification (OOS) microbiological results. The company inappropriately averaged test results to mask fungal contamination in components used for over-the-counter drug products, which eventually led to a Class I recall. Furthermore, the facility lacked validated cleaning procedures for mold and failed to perform required environmental monitoring. The FDA also cited a systemic failure of the Quality Unit, noting a lack of stability testing records since 2020 and the failure to complete annual product reviews. Additionally, certain products were identified as unapproved new drugs based on their labeling and website claims.

While the company has suspended drug production, the FDA requires comprehensive corrective actions before operations can resume. Silgan must provide a retrospective review of all OOS results, implement a remediation plan for its quality and investigation systems, and submit validation studies for its cleaning and manufacturing processes. The firm is also required to engage an independent consultant for a full six-system audit and must notify the FDA prior to restarting any manufacturing activities.