# FDA 483 - Cardionics, Inc - August 30, 2023

Source: https://www.globalkeysolutions.net/records/483/cardionics-inc/ee131ca3-3691-4ecd-8033-4cd04bb50011

> FDA 483 for Cardionics, Inc on August 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardionics, Inc
- Inspection Date: 2023-08-30
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Cardionics, Inc., a medical device manufacturer in Webster, TX, was cited with two observations during an FDA inspection. The firm failed to adequately document rework activities, specifically lacking determination of adverse effects on products and retention of failed test results. Additionally, the company's training procedures and records for personnel were found to be inadequately established and maintained.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/cardionics-inc/66b4e137-e0fb-444e-b17a-fffca655d53e

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