# FDA 483 - Silgan Unicep Packaging LLC - February 28, 2014

Source: https://www.globalkeysolutions.net/records/483/silgan-unicep-packaging-llc/a77638b4-f9b7-43f4-96bb-da63cc24ff19

> FDA 483 for Silgan Unicep Packaging LLC on February 28, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Silgan Unicep Packaging LLC
- Inspection Date: 2014-02-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Unicep compounding, filling & packaging in Sandpoint, ID, revealed two significant quality system deficiencies. The firm failed to adequately establish procedures for corrective and preventive actions, as evidenced by an unresolved issue with leaking pipettes. Additionally, procedures for routine equipment calibration were found to be inadequate, with a balance operating outside its acceptable tolerance range without proper action.

## Related Documents

- [483 - 2016-11-04](https://www.globalkeysolutions.net/records/483/silgan-unicep-packaging-llc/c5fc7245-5039-4e6a-bd5c-6387e89a9466)
- [483 - 2018-05-25](https://www.globalkeysolutions.net/records/483/silgan-unicep-packaging-llc/2150cfe1-a564-4e4e-aa48-ea061a9a8a15)

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/silgan-unicep-packaging-llc/7c3a3800-24a6-43a1-891d-f4647538de81

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