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

Source: https://www.globalkeysolutions.net/records/483/silgan-unicep-packaging-llc/bb172dde-2ad6-4bba-949e-7764be3e5d3b

> FDA 483 for Silgan Unicep Packaging Llc on June 14, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Silgan Unicep Packaging Llc
- Inspection Date: 2024-06-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Officers

- [Navneet Kaur](https://www.globalkeysolutions.net/people/navneet-kaur/23db67cc-7589-46f9-bbb9-930c0460500f)
- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Regulatory Affairs Specialist](https://www.globalkeysolutions.net/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)

Company: https://www.globalkeysolutions.net/companies/silgan-unicep-packaging-llc/9180ca81-2f21-4c9a-8753-c09a52073b27

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822