# FDA 483 - Katecho LLC - December 02, 2021

Source: https://www.globalkeysolutions.net/records/483/katecho-llc/16098184-cdb3-4112-b5e3-cb10d3f4a531

> FDA 483 for Katecho LLC on December 02, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Katecho LLC
- Inspection Date: 2021-12-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Katecho Inc., a contract manufacturer in Des Moines, IA, was cited for significant deficiencies in its quality system related to medical device manufacturing. The inspection revealed inadequate documentation of process validation activities, including justifications for single-lot validation and high reject rates, and a failure to properly establish process control procedures for microbiologic specifications. Additionally, the firm lacked proper documentation for rework activities and procedures for controlling non-conforming products, including investigations into test failures.

## Related Documents

- [483 - 2021-07-16](https://www.globalkeysolutions.net/records/483/katecho-llc/fac9d5ad-a626-4432-9c3c-be8b3e2d7c24)

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

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

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