# FDA 483 - Essential Safety PPE - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/essential-safety-ppe/286029f2-e31b-45da-8e18-38a5c49b7977

> FDA 483 for Essential Safety PPE on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Essential Safety PPE
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Essential Safety PPE in Houston, TX, a device manufacturer, revealed significant deficiencies in their quality system. The firm failed to conduct required management reviews and internal quality audits in 2023. Additionally, issues were noted with document change records and the availability of non-conformance reports during the inspection.

## Related Officers

- [Amber Smith](https://www.globalkeysolutions.net/people/amber-smith/2395fa1b-d091-4227-a340-9d6991c394fa)

Company: https://www.globalkeysolutions.net/companies/essential-safety-ppe/e87ff9d3-8750-4a88-9213-04078ce502f5

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9