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

The Food and Drug Administration (FDA) conducted an inspection of Silgan Unicep Packaging Llc, a drug filling and packaging facility located in Spokane, WA, from June 10 to June 14, 2024. The inspection revealed several issues related to the firm's adherence to regulatory requirements for drug manufacturing.

Key observations included deficiencies within the materials system, specifically that the company did not perform specific identification tests on components, relying instead on supplier reports. Component testing was found to be inadequate, as not all appropriate specifications for purity, strength, and quality were assessed. Additionally, the reliability of component supplier analyses was not regularly validated through comprehensive testing.

Concerning the quality system, the FDA noted that drug products were released for distribution without appropriate laboratory confirmation of conformance to final specifications, citing an instance where a lot was released with failing assay results. Furthermore, the laboratory system lacked proper controls over computerized equipment, such as the FTIR Spectrometer, which did not prevent the permanent deletion of raw data and lacked an audit trail, impacting data integrity.

These observations indicate a need for Silgan Unicep Packaging Llc to implement robust corrective and preventive actions to ensure compliance with current Good Manufacturing Practices (GMP) to safeguard the quality and safety of its drug products.