# FDA 483 - Paradigm Packaging West, LLC - January 28, 2020

Source: https://www.keypedia.com/records/483/paradigm-packaging-west-llc/2214d248-9256-4d33-9ed2-854fad9c58c9

> FDA 483 for Paradigm Packaging West, LLC on January 28, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paradigm Packaging West, LLC
- Inspection Date: 2020-01-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Peerless Injection Molding, LLC, a medical device manufacturer in Garden Grove, CA, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures and documentation for complaint handling, corrective and preventive actions, and personnel training. Additionally, the firm's Medical Device Reporting procedures were found to be incomplete and not fully implemented.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Sonya L. Karsik](https://www.keypedia.com/people/sonya-l-karsik/c24603b9-5ca0-46f5-861a-b367155b0def)

Company: https://www.keypedia.com/companies/paradigm-packaging-west-llc/3edf0b38-5dde-4378-8e2f-8e3156143c9f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6