# FDA 483 - Keystone Industries - July 25, 2025

Source: https://www.globalkeysolutions.net/records/483/keystone-industries/36b1dbb1-ba07-453d-bdf6-6aafd6dacbaf

> FDA 483 for Keystone Industries on July 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keystone Industries
- Inspection Date: 2025-07-25
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Keystone Industries, a medical device manufacturer in Cherry Hill, NJ, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included failures in medical device reporting, production process controls, corrective and preventive actions, complaint handling, supplier management, and internal quality audits. These issues indicate a systemic lack of adherence to regulatory requirements, potentially impacting product quality and patient safety.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/keystone-industries/50d3c3a5-4efb-4d90-9a9c-476e182324b8

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