# FDA 483 - Linatech, Llc - November 08, 2019

Source: https://www.globalkeysolutions.net/records/483/linatech-llc/a301793f-efd3-4896-8591-c290b79e65a6

> FDA 483 for Linatech, Llc on November 08, 2019. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Linatech, Llc
- Inspection Date: 2019-11-08
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Linatech, Llc, a repackager/relabeler in Sunnyvale, CA, was cited for numerous deficiencies in its quality system during an FDA inspection. The firm failed to establish adequate procedures for complaint handling, management reviews, quality planning, corrective and preventive actions, document control, and servicing activities. These issues indicate a fundamental lack of a robust quality management system.

## Related Documents

- [483 - 2021-09-29](https://www.globalkeysolutions.net/records/483/linatech-llc/a1ebd95b-932a-4f14-ab17-b4de279ca728)

## Related Officers

- [Amogh Pathi](https://www.globalkeysolutions.net/people/amogh-pathi/1325ce17-ca08-4cfb-818e-37889eccb31b)
- [investigator](https://www.globalkeysolutions.net/people/eric-j-heinze/f16828ab-f1e0-4556-bccc-700d93965b86)

Company: https://www.globalkeysolutions.net/companies/linatech-llc/ad0444d9-c00d-47a2-9bb7-e94dde896bc9

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