# FDA 483 - Personal Medical Corp. - July 19, 2019

Source: https://www.keypedia.com/records/483/personal-medical-corp/fe1c2430-f420-4cea-9137-97f0633a956d

> FDA 483 for Personal Medical Corp. on July 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Personal Medical Corp.
- Inspection Date: 2019-07-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Personal Medical Corp. in Redmond, WA, a manufacturer of Class I and Class II medical devices, revealed two significant observations. The firm failed to maintain adequate device history records, specifically lacking primary identification labels and unique device identifiers for manufactured lots. Additionally, the company did not have a documented quality policy established by executive management.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/personal-medical-corp/73e60f06-6d2f-426b-9bc9-95fa6a0d2189

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822