# FDA 483 - Seriously Clean, Ltd. - December 08, 2022

Source: https://www.keypedia.com/records/483/seriously-clean-ltd/5806624e-5534-4596-9251-119bee2fcf41

> FDA 483 for Seriously Clean, Ltd. on December 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seriously Clean, Ltd.
- Inspection Date: 2022-12-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Seriously Clean, Ltd. in Nixa, MO, a medical device manufacturer, was cited for inadequate quality system procedures during an FDA inspection. The firm failed to adequately establish and perform design validation and design verification activities for its Wound and Skin Care products. Additionally, products were shipped to customers before final acceptance and release procedures were completed.

## Related Documents

- [483 - 2018-03-28](https://www.keypedia.com/records/483/seriously-clean-ltd/04748832-c835-48c4-938f-7410d20741bc)

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/seriously-clean-ltd/fa2a25fb-25a9-4081-a09d-17c0715d6830

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