# FDA 483 - 3D Medical Manufacturing, Inc. - June 23, 2023

Source: https://www.globalkeysolutions.net/records/483/3d-medical-manufacturing-inc/76b30195-c27a-417f-b5c4-b421c34cae68

> FDA 483 for 3D Medical Manufacturing, Inc. on June 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 3D Medical Manufacturing, Inc.
- Inspection Date: 2023-06-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of 3D Medical Manufacturing, Inc. in Riviera Beach, FL, revealed deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company's process for escalating nonconformances to CAPAs was found inadequate, particularly concerning risk determination for legacy parts without clearly identified critical to quality (CTQ) dimensions. This could result in product defects, as evidenced by a customer complaint about sharp edges on a part causing sutures to break during surgery.

## Related Documents

- [483 - 2025-08-15](https://www.globalkeysolutions.net/records/483/3d-medical-manufacturing-inc/29e2fa2f-1f69-4c14-bd55-e89060fe37bd)

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6