# FDA 483 - Sandare International, Inc - November 02, 2021

Source: https://www.globalkeysolutions.net/records/483/sandare-international-inc/0ef47ad0-e7d9-455a-8141-6971df5e5eec

> FDA 483 for Sandare International, Inc on November 02, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandare International, Inc
- Inspection Date: 2021-11-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Sandare Intl., Inc. in Cedar Hill, TX, a device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included failures in process validation, incoming product inspection, equipment calibration, and document control. The firm also lacked adequate procedures for medical device reporting, supplier change agreements, design changes, nonconforming product, and corrective and preventive actions.

## Related Officers

- [Jennifer Cunningham](https://www.globalkeysolutions.net/people/jennifer-cunningham/5c332d60-b1e8-444f-8994-68cb1586c7eb)

Company: https://www.globalkeysolutions.net/companies/sandare-international-inc/787d7727-1943-4854-9428-bfdfa61d1f90

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