# FDA 483 - Amnii-X LLC - February 20, 2018

Source: https://www.keypedia.com/records/483/amnii-x-llc/89e2f444-6915-45fb-82de-2aac3e4ae37b

> FDA 483 for Amnii-X LLC on February 20, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amnii-X LLC
- Inspection Date: 2018-02-20
- Product Type: other
- Office Name: Dallas District Office
- Summary: GTR Medical Group, LLC, a human tissue storage/distributor in Plano, TX, was cited for two observations during an FDA inspection. The firm failed to perform and document corrective actions for out-of-range temperature excursions in its HCT/P storage room. Additionally, the inspection revealed that storage areas were not controlled to prevent mix-ups, specifically the co-mingling of expired and in-date HCT/Ps.

## Related Officers

- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)

Company: https://www.keypedia.com/companies/amnii-x-llc/e722e2fb-3132-4d41-aabe-d0866d61e617

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9