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

Source: https://www.keypedia.com/records/483/med-pen-concepts-llc/1708f01d-cc3d-44c8-aa4a-4f5d4186f67c

> FDA 483 for Med Pen Concepts, LLC on January 24, 2024. Product: Devices. 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: Devices
- Office Name: New England District Office
- Summary: The FDA conducted an inspection of Med Pen Concepts, LLC, a manufacturer located in Woburn, MA, from January 9 to January 24, 2024. The inspection revealed several significant compliance issues primarily related to the company's design verification, validation, and corrective and preventive action (CAPA) procedures. 

Key violations included the failure to adequately establish and follow procedures for design verification and validation. Specifically, Med Pen Concepts did not verify that design outputs met design inputs for their Plasma MD and Plasma+ devices, including critical aspects such as toxicity, biocompatibility, electrical performance, and thermal effects. Additionally, the company did not validate verification activities or document real-world clinical evidence of device performance as required before commercial distribution.

The inspection also highlighted deficiencies in the firm's CAPA procedures. Med Pen Concepts failed to effectively verify and validate action plans for several CAPAs, including issues related to applicator tip testing and device history record maintenance. Furthermore, the company did not adequately address previous FDA findings regarding power control improvements and risk assessments for distributed non-conforming products.

The FDA requires Med Pen Concepts to conduct internal audits to identify and rectify these violations to comply with quality system requirements. The firm is expected to implement corrective actions and submit responses detailing their plans to address the observations noted during the inspection.

## Related Documents

- [483 - 2022-04-13](https://www.keypedia.com/records/483/med-pen-concepts-llc/734c5c6f-d339-41fa-af68-491fcf8fc030)
- [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/f484e273-0768-4e42-917c-a54dbf9886aa)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/sunita-pandey-investigator/ddf84823-79ea-42d8-926a-8b857b8fcf28)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144