# FDA 483 - 3D Medical Manufacturing, Inc. - May 10, 2019

Source: https://www.globalkeysolutions.net/records/483/3d-medical-manufacturing-inc/8db218db-0128-48a6-8348-a1d212523e9e

> FDA 483 for 3D Medical Manufacturing, Inc. on May 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 3D Medical Manufacturing, Inc.
- Inspection Date: 2019-05-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Tec-Met, Inc. in Pennsauken, NJ, a contract manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. Observations included failures in finished device acceptance, in-process product control (specifically passivation), and inadequate corrective and preventive action procedures. Additionally, the firm failed to properly identify accepted incoming raw materials and ensure routine calibration of measuring equipment, indicating systemic issues in their quality management.

## Related Documents

- [483 - 2022-09-15](https://www.globalkeysolutions.net/records/483/3d-medical-manufacturing-inc/23474cf9-6b31-4846-9b3a-fd6b1da33270)

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/3d-medical-manufacturing-inc/abe2de00-37a0-488a-9f38-308064ab6afb

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e