# FDA 483 - Kobold, LLC - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/kobold-llc/9708fddc-8edd-4c79-84a0-e5bb2f758217

> FDA 483 for Kobold, LLC on August 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kobold, LLC
- Inspection Date: 2019-08-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Kobold, LLC, a manufacturer of brachytherapy devices in Liberty Lake, WA, was cited for multiple deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for design review, design change, supplier evaluation and monitoring, document control, and labeling activities. These issues indicate a systemic lack of adherence to established quality processes and documentation requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.globalkeysolutions.net/companies/kobold-llc/6c791a8f-cf36-4342-9bc8-22ad5ca15669

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822