# FDA 483 - Advanced Back Technologies, Inc. - October 31, 2024

Source: https://www.keypedia.com/records/483/advanced-back-technologies-inc/de92b54a-e241-4192-b935-3abfd53736a1

> FDA 483 for Advanced Back Technologies, Inc. on October 31, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Back Technologies, Inc.
- Inspection Date: 2024-10-31
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Advanced Back Technologies, Inc. in Syosset, NY, a manufacturer of Class II medical devices, identified four significant quality system deficiencies. These observations primarily concern inadequate maintenance of device history records, lack of formal agreements with contractors for product change notifications, and deficiencies in established procedures for corrective and preventive actions and design changes. The findings indicate a need for improved documentation and procedural controls to ensure product quality and regulatory compliance.

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/advanced-back-technologies-inc/383741d3-e575-43b2-bbe7-ee00f686f9af

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d