# FDA 483 - Athena GTX Inc. - April 21, 2022

Source: https://www.keypedia.com/records/483/athena-gtx-inc/dbb2741e-5d49-40e7-9ca6-4601e4a8d15b

> FDA 483 for Athena GTX Inc. on April 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Athena GTX Inc.
- Inspection Date: 2022-04-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Athena GTX Inc. in Johnston, IA, identified two significant observations. The firm lacked adequate procedures for monitoring and controlling process parameters, specifically for verifying unique device identifier (UDI) or universal product code (UPC) information. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, with a specific SOP missing instructions for evaluating Medical Device Reportability.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/athena-gtx-inc/cb6c65cb-d494-4822-be0d-e7e39e1e652e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8