# FDA 483 - Linatech, Llc - September 29, 2021

Source: https://www.globalkeysolutions.net/records/483/linatech-llc/a1ebd95b-932a-4f14-ab17-b4de279ca728

> FDA 483 for Linatech, Llc on September 29, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Linatech, Llc
- Inspection Date: 2021-09-29
- Product Type: device
- Office Name: Denver District Office
- Summary: Linatech, Llc, a class II medical device manufacturer in Sunnyvale, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and follow procedures for complaint handling, servicing activities, document control, quality audits, and employee training. These issues indicate a systemic lack of control over critical processes for ensuring device quality and patient safety.

## Related Documents

- [483 - 2019-11-08](https://www.globalkeysolutions.net/records/483/linatech-llc/a301793f-efd3-4896-8591-c290b79e65a6)

## Related Officers

- [Cso](https://www.globalkeysolutions.net/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

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

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face