# FDA 483 - Mlife Diagnostics LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/mlife-diagnostics-llc/9f76b8fa-2507-4b4e-9eab-d87d27dee1ed

> FDA 483 for Mlife Diagnostics LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mlife Diagnostics LLC
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: MLC Diagnostics LLC, a device manufacturer in Marshall, TX, was inspected on May 15, 2025. The inspection revealed significant deficiencies in the firm's quality system, specifically the absence of established recall procedures and incomplete device history records. These findings indicate a need for improved quality management and record-keeping practices.

## Related Officers

- [Amber Smith](https://www.globalkeysolutions.net/people/amber-smith/2395fa1b-d091-4227-a340-9d6991c394fa)

Company: https://www.globalkeysolutions.net/companies/mlife-diagnostics-llc/065a445e-cbf0-4f33-990c-07aece4f4d26

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab