# FDA 483 - Maxkron Machine, LLC - May 13, 2022

Source: https://www.keypedia.com/records/483/maxkron-machine-llc/18fa1473-2a07-4651-a736-c6a837bf5675

> FDA 483 for Maxkron Machine, LLC on May 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maxkron Machine, LLC
- Inspection Date: 2022-05-13
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Maxkron Machine, LLC, a medical device manufacturer in Valencia, CA, was inspected by the FDA. The inspection revealed that the firm failed to document process validation activities and their results for CNC machines used in manufacturing Class II Medical Devices. This indicates a deficiency in their quality system regarding equipment validation and record-keeping.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/maxkron-machine-llc/e23ed0a6-7ffa-411a-b2b4-2e7af7f6c416

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6