# FDA 483 - D R Burton Healthcare LLC - April 11, 2019

Source: https://www.globalkeysolutions.net/records/483/d-r-burton-healthcare-llc/2f68bb4f-458d-49d0-bb2a-b9f150a0fc1e

> FDA 483 for D R Burton Healthcare LLC on April 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: D R Burton Healthcare LLC
- Inspection Date: 2019-04-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: B R Burton Healthcare LLC, a medical device manufacturer in Farmville, NC, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately establish and implement procedures for corrective and preventive actions, complaint investigations, process validation, device history records, and in-process product acceptance. Additionally, sampling plans lacked valid statistical rationale, indicating significant issues with their quality management system.

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/d-r-burton-healthcare-llc/f5990aa9-0c96-4aaa-be0f-65a569063b44

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6