FDA WARNING_LETTER - CXL-USA, LLC - August 19, 2014

On August 18-19, 2014, the FDA inspected CXL-USA, LLC, regarding its role as a sponsor of a clinical investigation (Protocol (b)(4)) involving the investigational drug (b)(4). The inspection, part of theFDA's Bioresearch Monitoring Program, aimed to evaluate research conduct and human subject protection.

The FDA concluded that CXL-USA, LLC, failed to adhere to statutory requirements and FDA regulations. Key violations include:

1. **Failure to submit an Investigational New Drug (IND) application:** CXL-USA, LLC, studied the efficacy of (b)(4) for treating (b)(4), which meets the definition of a drug. An IND was required before conducting the clinical investigation, as (b)(4) is not a lawfully marketed drug in the U.S. and does not qualify for an IND exemption. CXL-USA, LLC, initiated Protocol (b)(4) and enrolled human subjects at 15 sites starting in 2009 without an IND. Although an IND was submitted on September 12, 2014, this was after the investigation began, rendering the response inadequate.

2. **Failure to ensure proper monitoring of clinical investigations:** CXL-USA, LLC, did not review investigation-related data or records, perform site monitoring, and relied on clinical site "self-monitoring." The company'