# FDA 483 - Imagine Milling Technologies, LLC - February 01, 2023

Source: https://www.keypedia.com/records/483/imagine-milling-technologies-llc/5c49b838-2ec5-4609-bdce-ee58a2579492

> FDA 483 for Imagine Milling Technologies, LLC on February 01, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Imagine Milling Technologies, LLC
- Inspection Date: 2023-02-01
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Imagine Milling Technologies, LLC, a medical device manufacturer in Chantilly, VA, received a Form FDA-483 with a repeat observation during an inspection from January 30 to February 1, 2023. The firm failed to perform required quality audits, providing evidence only for a 2019 third-party audit and admitting no internal audits were conducted from 2020-2022. This indicates a significant and recurring lapse in their quality system oversight.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/imagine-milling-technologies-llc/dd83624e-7322-4dd6-ad72-c9a910311e08

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64