# FDA 483 - Medscience Research Group Inc - August 26, 2022

Source: https://www.globalkeysolutions.net/records/483/medscience-research-group-inc/c5c60ee1-9d48-4630-8f96-5676cee3c6a3

> FDA 483 for Medscience Research Group Inc on August 26, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medscience Research Group Inc
- Inspection Date: 2022-08-26
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Medscience Research Group Inc. in West Palm Beach, FL, was issued a Form FDA 483 with five observations, all of which were repeat observations from a previous inspection in 2016. The inspection revealed significant deficiencies in the firm's quality system, including failures to establish and follow procedures for design control, supplier management, acceptance activities, corrective and preventive actions, and quality audits. These issues indicate a systemic lack of adherence to quality system regulations for medical device manufacturing.

## Related Officers

- [David M. Wilkinson](https://www.globalkeysolutions.net/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.globalkeysolutions.net/companies/medscience-research-group-inc/f96b9920-4430-4a44-a724-69a9b0552a2d

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6