# FDA 483 - 21st Century Scientific Inc - September 17, 2021

Source: https://www.keypedia.com/records/483/21st-century-scientific-inc/e08d75f3-768b-4b11-867a-5f43ad3922d4

> FDA 483 for 21st Century Scientific Inc on September 17, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 21st Century Scientific Inc
- Inspection Date: 2021-09-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of 21st Century Scientific Inc, a medical device manufacturer in Coeur D'Alene, ID, revealed significant deficiencies in their quality management system. The firm failed to adequately control nonconforming products, establish proper purchasing and incoming product acceptance procedures, and maintain adequate training documentation. Additionally, the firm's COO was found to be auditing areas for which he had direct responsibility, compromising audit independence.

## Related Documents

- [WARNING_LETTER - 2018-09-12](https://www.keypedia.com/records/warning_letter/21st-century-scientific-inc/328f177f-48b1-4db0-93f6-16f8925d1383)

## Related Officers

- [Eileen M. Malecki](https://www.keypedia.com/people/eileen-m-malecki/775204bb-a174-4bf9-93dc-03c300f81af0)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/21st-century-scientific-inc/817a7c04-70de-4053-bbb3-be76a2925b4a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6