# FDA 483 - Baylab USA, LLC - May 20, 2025

Source: https://www.globalkeysolutions.net/records/483/baylab-usa-llc/4fe3dcc2-cf36-4726-a77d-8b42ed48589f

> FDA 483 for Baylab USA, LLC on May 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baylab USA, LLC
- Inspection Date: 2025-05-20
- Product Type: device
- Office Name: Dallas District Office
- Summary: Baylab USA, LLC, a manufacturer of Class II face masks in Dallas, TX, received a Form FDA 483 with six repeat observations. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of established design controls, inadequate supplier management, and failure to conduct internal quality audits. Additionally, the firm lacked written medical device reporting procedures and failed to comply with Unique Device Identifier (UDI) labeling and GUDID submission requirements for its medical devices.

## Related Documents

- [483 - 2024-01-31](https://www.globalkeysolutions.net/records/483/baylab-usa-llc/a20f3fe2-552e-42a1-ab82-41a90502703b)
- [WARNING_LETTER - 2024-01-31](https://www.globalkeysolutions.net/records/warning_letter/baylab-usa-llc/60620309-bb04-48c7-a2a4-c6c6d4950520)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/baylab-usa-llc/8c515d41-dd10-46bf-b1cc-fa18b8527ea1

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