# FDA 483 - Merits Health Products, Inc. - December 06, 2022

Source: https://www.globalkeysolutions.net/records/483/merits-health-products-inc/87a70d3a-838d-4306-acd5-045a1e1ba36e

> FDA 483 for Merits Health Products, Inc. on December 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merits Health Products, Inc.
- Inspection Date: 2022-12-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Merits Health Products, Inc. in Fort Myers, FL, an importer and contract manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, control of nonconforming products, complaint handling, supplier evaluation, and labeling activities. These issues indicate significant gaps in the firm's quality management system.

## Related Documents

- [483 - 2025-02-27](https://www.globalkeysolutions.net/records/483/merits-health-products-inc/b076db50-f3c2-42e2-ae66-bd9c16af8a17)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/merits-health-products-inc/8d8b45ca-d695-4945-add4-2f083d14bd3e

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