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

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