# FDA 483 - New Star Lasers, Inc. - March 20, 2017

Source: https://www.globalkeysolutions.net/records/483/new-star-lasers-inc/6029e165-6a33-45a3-b9cc-5796f15d1ef4

> FDA 483 for New Star Lasers, Inc. on March 20, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Star Lasers, Inc.
- Inspection Date: 2017-03-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: New Star Lasers, Inc. in Roseville, CA, a device manufacturer, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, including failures to adequately establish and implement CAPA procedures, define effectiveness criteria, conduct effectiveness checks, and properly document CAPA activities and results. These issues indicate a systemic problem with the firm's quality management system.

## Related Officers

- [Linda Linh T Nguyen](https://www.globalkeysolutions.net/people/linda-linh-t-nguyen/b3f67f72-5aae-442a-8c46-535b2b709955)

Company: https://www.globalkeysolutions.net/companies/new-star-lasers-inc/37aa2f44-25b0-45d2-9a0e-efd9fbedbc61

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b