# FDA 483 - LSI Solutions, Inc. - October 04, 2018

Source: https://www.globalkeysolutions.net/records/483/lsi-solutions-inc/770f5307-8cd5-408d-a088-cbe346d96c7f

> FDA 483 for LSI Solutions, Inc. on October 04, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LSI Solutions, Inc.
- Inspection Date: 2018-10-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of LSI Solutions, Inc. in Victor, NY, a medical device manufacturer, revealed significant deficiencies in their corrective and preventive action (CAPA) system. The firm failed to adequately document CAPA activities and results, and their CAPA procedures were not fully established to describe necessary documentation requirements. These issues indicate a lack of robust quality system controls.

## Related Officers

- [Nicholas C Mendiola](https://www.globalkeysolutions.net/people/nicholas-c-mendiola/387f053a-af5f-4da9-8042-031124b9467d)

Company: https://www.globalkeysolutions.net/companies/lsi-solutions-inc/e0d93f62-a133-496e-bc2c-eaf846393968

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961