AMKS TIME RELEASE LAB, LLC – FDA EIR, Jul 12, 2013

An FDA inspection of AMKS TIME RELEASE LAB, LLC, conducted from June 17 to July 12, 2013, identified significant deviations from regulatory requirements governing clinical trials. The inspection, carried out under the Good Clinical Practice framework, focused on an Investigational New Drug (IND) submission (IND# 115097). Key violations included the failure to submit an IND application prior to initiating a clinical trial, and a complete absence of monitoring for the clinical investigation. The company also failed to obtain required financial disclosure information from its principal investigator and did not retain essential documents, specifically investigational product labels. Furthermore, AMKS TIME RELEASE LAB, LLC lacked adequate records for the shipment, use, return, and destruction of the investigational drug product. The FDA also noted a failure to provide investigators and clinical staff with appropriate general or study-specific training regarding federal regulations for clinical trials. These issues indicate a systemic lack of compliance with federal regulations concerning investigational new drug applications. An FDA Form-483 detailing these observations was issued to the company's President, who committed to submitting a written response within 15 business days to address the findings and implement corrective actions.