FDA 483 - Aphena Pharma Solutions - Tennessee LLC - December 12, 2013

Aphena Pharma Solutions-Tennessee, LLC, a drug repackager in Cookeville, TN, received a Form 483 with three observations. The inspection revealed deficiencies in the firm's investigation procedures, specifically regarding the scope of nonconformance investigations and the evaluation of reserve samples. Additionally, the firm's reserve drug product samples were found not to be representative of each lot, and visual examinations for deterioration were not conducted or recorded according to their own procedures.