# FDA 483 - Med Pen Concepts, LLC - April 13, 2022

Source: https://www.keypedia.com/records/483/med-pen-concepts-llc/734c5c6f-d339-41fa-af68-491fcf8fc030

> FDA 483 for Med Pen Concepts, LLC on April 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Med Pen Concepts, LLC
- Inspection Date: 2022-04-13
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Med Pen Concepts, Llc in Woburn, MA, was inspected regarding its manufacturing operations for a plasma device. The inspection revealed significant deficiencies across its quality system, including inadequate complaint handling, lack of documented CAPA activities, and failure to establish proper procedures for design changes and acceptance activities. Additionally, the firm lacked device history records, written MDR procedures, and evidence of internal quality audits and management reviews, indicating a broad breakdown in quality system compliance.

## Related Documents

- [WARNING_LETTER - 2022-04-13](https://www.keypedia.com/records/warning_letter/med-pen-concepts-llc/bda26b21-6083-474f-91e3-2083108d4641)
- [483 - 2024-01-24](https://www.keypedia.com/records/483/med-pen-concepts-llc/1708f01d-cc3d-44c8-aa4a-4f5d4186f67c)
- [483 - 2024-01-24](https://www.keypedia.com/records/483/med-pen-concepts-llc/f484e273-0768-4e42-917c-a54dbf9886aa)

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)
- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

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