# FDA 483 - Med Pen Concepts, LLC - January 24, 2024

Source: https://www.keypedia.com/records/483/med-pen-concepts-llc/f484e273-0768-4e42-917c-a54dbf9886aa

> FDA 483 for Med Pen Concepts, LLC on January 24, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Med Pen Concepts, LLC
- Inspection Date: 2024-01-24
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Med Pen Concepts, LLC in Woburn, MA, revealed 12 significant observations regarding their quality management system for Plasma Pen medical devices. The firm demonstrated widespread failures in design control, corrective and preventive actions, device history records, and various acceptance and validation procedures. Several issues were repeat observations from a previous inspection, indicating persistent non-compliance.

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## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/med-pen-concepts-llc/e4eabde0-6259-49e5-933a-af195da882b7

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94