# FDA 483 - Ingen Orthopedics LLC - May 03, 2023

Source: https://www.keypedia.com/records/483/ingen-orthopedics-llc/df94deeb-098c-462d-9207-e0ce2c536574

> FDA 483 for Ingen Orthopedics LLC on May 03, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ingen Orthopedics LLC
- Inspection Date: 2023-05-03
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Ingen Orthopedics LLC in Cranbury, NJ, a specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately establish training procedures for field representatives, which led to a complaint involving the use of an expired device. Additionally, several critical procedures lacked documented approval dates, indicating poor document control.

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)
- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

Company: https://www.keypedia.com/companies/ingen-orthopedics-llc/3a5a577e-517d-4f13-87f6-854386e92787

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