# FDA 483 - CardioQuip, LLC - September 17, 2021

Source: https://www.globalkeysolutions.net/records/483/cardioquip-llc/ae81c889-b31a-46ec-8853-0e3bc315ca54

> FDA 483 for CardioQuip, LLC on September 17, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CardioQuip, LLC
- Inspection Date: 2021-09-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of CardioQuip, LLC in College Station, TX, revealed significant deficiencies across multiple quality system areas for their MCH-1000 medical devices. The firm failed to adequately establish procedures for design changes, design validation, and risk analysis, particularly concerning microbial contamination and aerosolization risks. Furthermore, the company demonstrated inadequate complaint handling, medical device reporting (MDR) procedures, and corrective and preventive action (CAPA) documentation, leading to uninvestigated complaints and misclassified reportable events.

## Related Documents

- [WARNING_LETTER - 2021-09-17](https://www.globalkeysolutions.net/records/warning_letter/cardioquip-llc/3f57c600-cb82-40d7-9ede-dff67473e55c)

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/cardioquip-llc/fc77f9cb-e6a5-495b-8930-55ccd8a5dee6

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