What happened
FDA inspected Silgan Unicep Packaging’s Spokane, Washington, drug manufacturing facility from March 26 to April 2, 2026, and reported significant CGMP violations involving non-sterile OTC products. FDA found that the firm inadequately investigated OOS microbiological results for components. Individual yeast and mold failures were invalidated by averaging sample results to obtain passing outcomes, and the sampling plan was revised to permit averaging, which FDA said was inconsistent with USP and could obscure non-uniform contamination. Affected component lots were released and used in distributed product. FDA also found the investigation associated with a Class I recall for potential fungal contamination inadequate: a bioburden-reduction corrective action was ineffective, related change control lacked appropriate validation and evaluation, the manufacturing line lacked cleaning procedures and cleaning validation, and environmental monitoring omitted yeast and mold testing. Separately, FDA said the quality unit failed to ensure supplier test reliability, follow the written stability program, and complete annual product reviews. FDA deemed the responses inadequate because they lacked sufficient scope, supporting evidence, effectiveness verification, product-risk measures, and remediation of systemic quality oversight failures.
Why it matters
From a GMP perspective, invalidating individual microbiological failures through averaging may permit contaminated or non-uniform component lots to be accepted and used in drug products. Missing cleaning procedures, cleaning validation, and yeast-and-mold environmental monitoring could leave contamination risks unidentified or uncontrolled. Weak investigation scope, ineffective corrective action, and insufficient quality unit oversight may allow recurring failures and undermine confidence in batch disposition, supplier data, stability oversight, and the continuing state of control.
Key topics: Averaging of failing yeast and mold results to invalidate microbiological OOS findings, Inadequate fungal contamination investigation, cleaning validation, and environmental monitoring, Quality unit failures in supplier testing, stability studies, and annual product reviews