# FDA 483 - Libra Industries, LLC - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/libra-industries-llc/62d7adcb-5ccc-4a3d-8ae9-58ce4d8e932b

> FDA 483 for Libra Industries, LLC on August 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Libra Industries, LLC
- Inspection Date: 2019-08-02
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Libra Industries Dallas, a device manufacturer, revealed significant deficiencies in their quality system. The firm lacked established procedures for handling customer complaints, including oral complaints and medical device report evaluations. Additionally, procedures for documenting, evaluating, and investigating nonconforming products were not adequately defined or followed.

## Related Officers

- [ROX BABY, Consumer Safety Officer](https://www.globalkeysolutions.net/people/rox-baby-consumer-safety-officer/499de8d6-3753-4a36-b6a2-579f3b770009)
- [Jennifer Cunningham](https://www.globalkeysolutions.net/people/jennifer-cunningham/5c332d60-b1e8-444f-8994-68cb1586c7eb)

Company: https://www.globalkeysolutions.net/companies/libra-industries-llc/936175eb-cbf8-473d-b783-2ed2d55f502b

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