FDA 483 - AMKS TIME RELEASE LAB, LLC - June 17, 2013

An FDA inspection conducted between June 17 and July 12, 2013, at a firm led by Ismail Elchagea, President, revealed significant non-compliance related to a clinical study involving an investigational new drug. The inspection, documented in an FDA Form 483, identified multiple critical issues concerning the conduct and oversight of clinical research.

The primary violation was the firm's failure to submit an Investigational New Drug (IND) Application to the FDA prior to initiating the clinical trial, which is a fundamental regulatory requirement for human drug investigations. Furthermore, the company failed to adequately monitor the study's progress, neglecting to draft a monitoring plan or conduct any monitoring activities. Record-keeping was also deficient, with a lack of retained investigational product labels and no records detailing the receipt, shipment, or disposition of the investigational drug.

Other significant observations included the failure to obtain updated financial disclosure commitments from investigators and a lack of proper training for clinical investigators and staff regarding applicable Code of Federal Regulations. These observations highlight a systemic failure to adhere to established guidelines for conducting clinical research. Corrective actions are required to address these deficiencies and ensure future compliance with FDA regulations.