FDA 483 - Silgan Unicep Packaging Llc - June 14, 2024

Silgan Unicep Packaging Llc in Spokane, WA, was inspected for drug filling and packaging operations. The inspection revealed significant deficiencies in component testing, including reliance on unvalidated supplier certificates of analysis and failure to perform specific identification tests. Additionally, the firm released drug product lots with failing assay results and lacked adequate controls over computerized laboratory systems, compromising data integrity.