# FDA 483 - Liberty Mask LLC - December 15, 2023

Source: https://www.globalkeysolutions.net/records/483/liberty-mask-llc/40ae694f-b31a-46ac-9128-c258b80e0587

> FDA 483 for Liberty Mask LLC on December 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Liberty Mask LLC
- Inspection Date: 2023-12-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Liberty Mask LLC, a manufacturer of KN95 Style Face Masks in Richardson, TX, was cited for numerous quality system deficiencies during an FDA inspection. The firm failed to establish adequate design controls, purchasing controls, acceptance activities, process validation, and internal quality audits. Additionally, the company did not properly control non-conforming products, maintain a device master record, or comply with Unique Device Identifier (UDI) labeling and database submission requirements for its medical devices.

## Related Officers

- [Jacey Roy](https://www.globalkeysolutions.net/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.globalkeysolutions.net/companies/liberty-mask-llc/64299273-2e3f-4e51-aac7-9b4851f1ac49

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