# FDA Warning Letter: Baylab USA, LLC
> 2024-08-13 · OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality · `2f6d9c6532e21ebe`
## Letter
- **Company:** Baylab USA, LLC
- **Posted Date:** 2024-08-13
- **Letter Issue Date:** 2024-06-27
- **Issuing Office:** OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality
## Subject
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
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*Source: [FDA Warning Letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) · AI Analytics · CC0 1.0*