# FDA 483 - DiaPharma Group Inc - April 29, 2022

Source: https://www.globalkeysolutions.net/records/483/diapharma-group-inc/f39982cd-9155-433c-b756-f215adf693ec

> FDA 483 for DiaPharma Group Inc on April 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DiaPharma Group Inc
- Inspection Date: 2022-04-29
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: DiaPharma Group Inc. in West Chester, OH, was inspected by the FDA from April 26-29, 2022. The inspection revealed a significant issue with the firm's design change procedures, specifically the lack of validation for design changes. This deficiency led to a packaging design change for a Factor X Kit being implemented and shipped without proper validation, despite being initiated due to customer complaints about broken vials.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.globalkeysolutions.net/companies/diapharma-group-inc/1778c90b-7a40-4a54-b058-a6f4ec274e7a

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22