# FDA 483 - Baylab USA, LLC - January 31, 2024

Source: https://www.keypedia.com/records/483/baylab-usa-llc/0926035e-357f-470e-91ad-71a829d6ea23

> FDA 483 for Baylab USA, LLC on January 31, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baylab USA, LLC
- Inspection Date: 2024-01-31
- Product Type: devices
- Office Name: Dallas District Office
- Summary: An FDA inspection conducted from January 24-31, 2024, at Baylab USA, LLC, a manufacturer and distributor of face masks and imported medical devices in Dallas, TX, identified significant deficiencies in its quality system. The inspection revealed nine observations indicating non-compliance with medical device regulations. Key issues for their ASTM Level 3 Surgical Face Masks, a Class II medical device, included the absence of established design controls, encompassing design plans, input/output documentation, validation, risk analysis, and a design history file. The company also lacked adequate purchasing controls, failing to conduct consistent supplier assessments or establish quality agreements. Furthermore, internal quality audits had not been performed since the firm's initiation in 2019. Additional concerns involved insufficient training procedures for quality control and production staff, and the complete absence of corrective and preventive action (CAPA) and complaint-handling procedures, despite documented complaints regarding imported nitrile gloves. Baylab USA also failed to develop and implement Medical Device Report (MDR) procedures, validate manufacturing processes for the masks, or ensure devices bore a Unique Device Identifier (UDI) with corresponding information submitted to the FDA's Global Unique Device Identification Database (GUDID). These observations necessitate Baylab USA promptly establish and adhere to a comprehensive quality system to ensure product safety and regulatory compliance.

## Related Documents

- [483 - 2024-01-31](https://www.keypedia.com/records/483/baylab-usa-llc/a20f3fe2-552e-42a1-ab82-41a90502703b)
- [WARNING_LETTER - 2024-01-31](https://www.keypedia.com/records/warning_letter/baylab-usa-llc/60620309-bb04-48c7-a2a4-c6c6d4950520)
- [483 - 2025-05-20](https://www.keypedia.com/records/483/baylab-usa-llc/4fe3dcc2-cf36-4726-a77d-8b42ed48589f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-c-stephens/54fcc669-ab35-479b-a2f7-5c4d746a3144)
- [Phillip C. Trefsgar](https://www.keypedia.com/people/phillip-c-trefsgar/8034282c-6b16-46e7-9a56-dbe32e0b99dd)

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

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