# FDA 483 - 3D Medical Manufacturing, Inc. - August 15, 2025

Source: https://www.keypedia.com/records/483/3d-medical-manufacturing-inc/29e2fa2f-1f69-4c14-bd55-e89060fe37bd

> FDA 483 for 3D Medical Manufacturing, Inc. on August 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 3D Medical Manufacturing, Inc.
- Inspection Date: 2025-08-15
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of 3D Medical Manufacturing, Inc. in Riviera Beach, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, properly investigate complaints, control nonconforming products, and document process validation activities. These issues indicate systemic problems in maintaining a compliant quality management system.

## Related Documents

- [483 - 2023-06-23](https://www.keypedia.com/records/483/3d-medical-manufacturing-inc/76b30195-c27a-417f-b5c4-b421c34cae68)

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/3d-medical-manufacturing-inc/4fbd0b04-f308-424b-8f51-1c2850549d42

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9