# FDA 483 - Katecho LLC - July 16, 2021

Source: https://www.globalkeysolutions.net/records/483/katecho-llc/fac9d5ad-a626-4432-9c3c-be8b3e2d7c24

> FDA 483 for Katecho LLC on July 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Katecho LLC
- Inspection Date: 2021-07-16
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Katecho Inc. in Des Moines, IA, was inspected by the FDA, resulting in four observations related to quality system deficiencies. The inspection revealed issues with process validation, including inadequate standards and undocumented procedures, as well as failures in monitoring validated process parameters. Additionally, the firm had significant shortcomings in its corrective and preventive action (CAPA) documentation and its procedures for handling and evaluating customer complaints.

## Related Documents

- [483 - 2021-12-02](https://www.globalkeysolutions.net/records/483/katecho-llc/16098184-cdb3-4112-b5e3-cb10d3f4a531)

## Related Officers

- [Clifford F. Long](https://www.globalkeysolutions.net/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)
- [investigator](https://www.globalkeysolutions.net/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

Company: https://www.globalkeysolutions.net/companies/katecho-llc/11bd1e06-f3f2-490a-b3a6-0389195503d1

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d