# FDA 483 - Titan Implants, Inc - February 20, 2025

Source: https://www.keypedia.com/records/483/titan-implants-inc/1d64db09-d882-437f-992b-08755874cab2

> FDA 483 for Titan Implants, Inc on February 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Titan Implants, Inc
- Inspection Date: 2025-02-20
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Titan Implants, Inc. in Bergenfield, NJ, a manufacturer of implants, revealed two significant quality system deficiencies. The firm failed to adequately document corrective and preventive actions, a repeat finding from a previous inspection. Additionally, the company did not properly establish requirements for suppliers and consultants, including review of purchasing documents and continuous monitoring of quality performance.

## Related Documents

- [483 - 2023-03-16](https://www.keypedia.com/records/483/titan-implants-inc/5f5a2b17-fbfe-41c1-b848-065dd236903b)

## Related Officers

- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

Company: https://www.keypedia.com/companies/titan-implants-inc/a6f522ee-fec0-496a-a083-c7a1c1cafb2e

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248