# FDA 483 - Peace Medical Inc. - January 14, 2025

Source: https://www.keypedia.com/records/483/peace-medical-inc/16fb368e-eca1-4c48-ae90-1f6ef6fd5984

> FDA 483 for Peace Medical Inc. on January 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Peace Medical Inc.
- Inspection Date: 2025-01-14
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Peace Medical Inc., a medical device manufacturer in Wharton, NJ, revealed significant deficiencies in their quality system. Observations included inadequate purchasing controls, a failure to implement Unique Device Identifiers (UDI) on device labels, and a lack of submission of required device information to the Global Unique Device Identification Database (GUDID). These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing and labeling.

## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)
- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

Company: https://www.keypedia.com/companies/peace-medical-inc/40e0485e-ad9c-4db8-9821-b62b69520a82

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