# FDA 483 - Digital Diagnostics Inc. - November 10, 2022

Source: https://www.keypedia.com/records/483/digital-diagnostics-inc/f0685834-ebdb-4c54-b27e-60ee20af022c

> FDA 483 for Digital Diagnostics Inc. on November 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Digital Diagnostics Inc.
- Inspection Date: 2022-11-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Digital Diagnostics Inc., a medical device manufacturer in Coralville, IA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding the analysis of complaints for non-conforming products. Additionally, the company did not maintain proper records for non-reportable device corrections, indicating a lack of adherence to their own procedures and regulatory requirements.

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/digital-diagnostics-inc/d86bc06e-7ba0-4013-b103-023afb3f0e47

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