# FDA 483 - Dalton Medical Corp - September 15, 2022

Source: https://www.keypedia.com/records/483/dalton-medical-corp/c1f89f68-86e9-4046-b3f6-4bb67bc7bea8

> FDA 483 for Dalton Medical Corp on September 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dalton Medical Corp
- Inspection Date: 2022-09-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Dalton Medical Corp, a specification developer and importer in Farmers Branch, TX, was cited with 10 observations during an FDA inspection from September 7-15, 2022. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for design control, complaint handling, supplier evaluation, MDR reporting, service reports, sampling plans, CAPA, quality audits, management review, and employee training. Several observations were repeats from a previous inspection, indicating persistent systemic issues.

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/dalton-medical-corp/0d433cf2-4d23-45c3-b458-1155ea50d411

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab