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

Source: https://www.keypedia.com/records/warning_letter/baylab-usa-llc/60620309-bb04-48c7-a2a4-c6c6d4950520

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Baylab USA, LLC
- Inspection Date: 2024-01-31
- Product Type: Devices
- Office Name: Office of Health Technology 4 (Surgical and Infection Control Devices)
- Summary: On June 27, 2024, the FDA issued a Warning Letter to Baylab USA, LLC, following an inspection from January 24-31, 2024, in Dallas, TX. The firm manufactures and distributes the Class II BAYLAB 3-Ply Surgical Mask (ASTM Level 3 Mask), ASTM Level 1 Baylab 3-Ply Earloop Face Mask (ASTM Level 1 Mask), and KN95 Respirator, all intended for medical use.

The FDA found that the ASTM Level 1 Mask, KN95 Respirator, and certain versions of the ASTM Level 3 Mask are adulterated because they lack premarket approval (PMA) or investigational device exemption (IDE). The ASTM Level 3 Mask is also misbranded due to major changes in material and intended use (e.g., new colors, pediatric sizes, printed logos) without a new 510(k) premarket notification. The ASTM Level 1 Mask and KN95 Respirator are misbranded for not submitting a 510(k) notification prior to commercial distribution.

Additionally, the devices are adulterated under Quality System Regulation (21 CFR Part 820) for:
1. Failure to establish and maintain design controls, including a design history file, design validation, and risk analysis (21 CFR § 820.30(a), (g), (j

## Related Documents

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

## Related Officers

- [Director](https://www.keypedia.com/people/binita-s-ashar/5a2f78e1-1ad7-4bf2-b980-eb925e2c765e)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)

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

Office: https://www.keypedia.com/offices/office-of-health-technology-4-surgical-and-infection-control-devices/c8035073-57c9-474f-a673-3583da06932e