Silgan Unicep Packaging LlcJune 14, 2024

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

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Record Details

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.

Company: Silgan Unicep Packaging Llc
Inspection Date: June 14, 2024
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West VI
People: Navneet Kaur
Khoa Nathan V. Tran (issuing_officer)
Andrew Le (Regulatory Affairs Specialist)

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ID · bb172dde-2ad6-4bba-949e-7764be3e5d3b