# FDA 483 - Pointcore Supply Chain Service LLC - June 26, 2025

Source: https://www.globalkeysolutions.net/records/483/pointcore-supply-chain-service-llc/a07dc63c-0a58-4da7-a1f5-08982e254c0f

> FDA 483 for Pointcore Supply Chain Service LLC on June 26, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pointcore Supply Chain Service LLC
- Inspection Date: 2025-06-26
- Product Type: other
- Office Name: Chicago District Office
- Summary: Pointcore Supply Chain Service LLC in Peoria, IL was inspected, revealing significant deficiencies in its quality system. The inspection found a pervasive lack of established and implemented procedures for critical quality functions, including quality plans, CAPA, complaint handling, management review, quality audits, and design change. Management also demonstrated a lack of awareness regarding the firm's quality policy and the designated management representative lacked necessary training, indicating a fundamental breakdown in quality system oversight for their Class II medical devices.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/pointcore-supply-chain-service-llc/9d66bf29-8116-441f-ba3b-c8d9887d64df

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669