FDA WARNING_LETTER - AMKS TIME RELEASE LAB, LLC - July 12, 2013

The FDA issued a Warning Letter to AMKS Time Release Laboratories, LLC (AMKS TRL) following an inspection from June 17 to July 12, 2013, regarding their clinical investigation (Protocol (b)(4)) of the investigational drug (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified significant violations of FDA regulations.

AMKS TRL failed to submit an Investigational New Drug (IND) application for (b)(4), which the FDA determined meets the definition of a drug due to its intended use in treating hepatitis C and HIV. The company's claim that (b)(4) was a dietary supplement was rejected. While AMKS TRL committed to not initiating further studies without FDA authorization, their July 30, 2013, response was deemed inadequate regarding monitoring and record-keeping.

Additionally, AMKS TRL failed to ensure proper monitoring of the investigation, lacking a written monitoring plan and failing to ensure the clinical investigator collected data on protocol-specific case report forms (CRFs). The provided CRF was also inconsistent with the protocol. Lastly, AMKS TRL did not maintain adequate records of the receipt, shipment, or disposition of the investigational drug, with their proposed SOP for future studies lacking sufficient detail or documentation.

AMKS TRL must address these deficiencies and establish procedures for future compliance. A written response detailing corrective actions is required within fifteen working days to avoid