# FDA 483 - DMD Medical Group - August 25, 2021

Source: https://www.globalkeysolutions.net/records/483/dmd-medical-group/52da4243-1224-4b9a-a4f0-59e8272ef90f

> FDA 483 for DMD Medical Group on August 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DMD Medical Group
- Inspection Date: 2021-08-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: DMD Medical Group, an initial import/distributor in Chesterfield, SC, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection found a complete absence of written procedures for critical functions including complaint handling, medical device reporting (MDRs), and corrective and preventive actions (CAPA). These findings indicate a fundamental lack of established processes for managing product quality and safety.

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/dmd-medical-group/54de3233-a84a-449f-99c3-90ced137b337

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0