# FDA 483 - Micro Distributing I I, Ltd - March 07, 2023

Source: https://www.globalkeysolutions.net/records/483/micro-distributing-i-i-ltd/9c2e03ff-a6ca-45c2-a15c-4c631ef304d4

> FDA 483 for Micro Distributing I I, Ltd on March 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Distributing I I, Ltd
- Inspection Date: 2023-03-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: During an inspection, Micro Distributing I I, Ltd in Belton, TX, was cited for significant deficiencies in its quality system. The firm failed to establish written procedures for handling customer complaints and did not develop, maintain, or implement written Medical Device Reporting (MDR) procedures. These issues indicate a lack of robust processes for post-market surveillance and regulatory compliance.

## Related Officers

- [Katlin N. Stubbs](https://www.globalkeysolutions.net/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.globalkeysolutions.net/companies/micro-distributing-i-i-ltd/2182384c-963d-41f3-b073-c5d3e553de2e

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