# FDA 483 - James Consolidated, Inc. - November 03, 2020

Source: https://www.globalkeysolutions.net/records/483/james-consolidated-inc/e334ec06-8315-4808-89a5-c4ca31815f30

> FDA 483 for James Consolidated, Inc. on November 03, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James Consolidated, Inc.
- Inspection Date: 2020-11-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of James Consolidated, Inc. in Concord, CA, revealed significant deficiencies in their quality system for manufacturing and distributing The Volkner Turning System, a Class 2 medical device. The firm failed to establish and maintain numerous critical procedures, including those for corrective and preventive actions, device master records, quality audits, supplier control, complaint handling, management review, design control, non-conforming product, and medical device reporting. Additionally, the firm did not document acceptance activities or complaints.

## Related Officers

- [Jeffrey S Buckser](https://www.globalkeysolutions.net/people/jeffrey-s-buckser/deea4f9e-858f-4325-828e-56044c40a570)
- [Christopher W. Buser](https://www.globalkeysolutions.net/people/christopher-w-buser/6a11d2e7-dcfa-4542-ba81-b4c6b244ef04)
- [investigator](https://www.globalkeysolutions.net/people/harjap-k-atwal/7fb8b398-b01b-43c6-9107-cc4ceedec0ca)
- [investigator](https://www.globalkeysolutions.net/people/maida-henesian/cd28e878-000c-4af8-8dbd-4863057758bb)

Company: https://www.globalkeysolutions.net/companies/james-consolidated-inc/d57d5d10-7190-4e39-9eac-e078a4cab0a2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b