# FDA 483 - PJM World Wide LLC - November 04, 2024

Source: https://www.globalkeysolutions.net/records/483/pjm-world-wide-llc/b2dfa0be-2dd4-405c-9681-ab4a1e19542e

> FDA 483 for PJM World Wide LLC on November 04, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PJM World Wide LLC
- Inspection Date: 2024-11-04
- Product Type: device
- Office Name: Florida District Office
- Summary: PJM World Wide LLC, a specification developer in Doral, FL, was cited for numerous significant deficiencies in its quality system for Class II medical devices during an FDA inspection. The firm failed to establish fundamental procedures for complaint handling, design control, supplier management, servicing, acceptance activities, Medical Device Reporting (MDR), corrective and preventive actions (CAPA), document control, and overall quality system management. Additionally, the firm's medical device labels lacked Unique Device Identifiers (UDI), and required information was not submitted to the Global Unique Device Identifier Database (GUDID).

## Related Officers

- [Marvin A. Marenco](https://www.globalkeysolutions.net/people/marvin-a-marenco/b4638545-ba1f-4b1c-940f-7c18c5f436ed)

Company: https://www.globalkeysolutions.net/companies/pjm-world-wide-llc/3a3d9191-c7f7-4488-8d25-8b7cee087cdc

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9