FDA EIR - Aphena Pharma Solutions - Tennessee LLC - December 12, 2013

An FDA inspection of Aphena Pharma Solutions-Tennessee, LLC, a drug repacker and relabeler in Cookeville, TN, occurred from December 10-12, 2013. The inspection, covering pre-approval processes and abbreviated quality and packaging/labeling systems, revealed significant deviations from Current Good Manufacturing Practice (cGMP) regulations.

The FDA issued a Form 483 detailing three main violations. Firstly, the company's investigations into product discrepancies, such as a mix-up complaint, were insufficient. They failed to encompass all potentially associated drug product lots or evaluate reserve samples, contrary to regulations requiring thorough investigations. Secondly, reserve drug product samples were not consistently representative of each lot or batch, often comprising incomplete quantities or being collected inadequately, violating established standards for sample integrity. Thirdly, the firm failed to conduct periodic visual examinations of reserve samples for deterioration and lacked records of such examinations, which is a regulatory requirement for ongoing product quality assurance.

These observations point to systemic issues in the firm's quality control and sample management procedures. Aphena Pharma Solutions-Tennessee's management committed to a written response outlining corrective actions. The FDA emphasized the potential for legal sanctions if non-compliance is not adequately addressed.