Ashley Park, President
Justin C. Lee, Vice President of Strategic Planning, Development, and Operations
Baylab USA, LLC
2230 Lyndon B Johnson Fwy, Ste. 100
Dallas , TX 75234-7331
United StatesFEI 3017517827Issued Jun 27, 2024OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017517827.
Violations11
Issue DateJun 27, 2024
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Baylab USA, LLC
Location
Ashley Park, President
Justin C. Lee, Vice President of Strategic Planning, Development, and Operations
Baylab USA, LLC
2230 Lyndon B Johnson Fwy, Ste. 100
Dallas , TX 75234-7331
United States
FEI Number
3017517827
Country
United States
Issue Date
June 27, 2024
Issuing Office
OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality
Product Type
Medical Devices
Status
Open
Summary
Baylab USA, LLC manufactured and distributed surgical masks and respirators (ASTM Level 1 Mask, ASTM Level 3 Mask, and KN95 Respirator) intended for medical use without obtaining required FDA premarket approval (PMA) or investigational device exemption (IDE) authorizations, rendering these products adulterated under federal law. During a January 2024 inspection, FDA investigators determined that certain product versions lacked the necessary regulatory clearance despite being marketed for medical purposes including reducing exposure to particulates, bacteria, and blood or body fluids. The ASTM Level 3 Mask was additionally found to be misbranded for unapproved commercial distribution into interstate commerce.
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