FDA 483 - Aphena Pharma Solutions - Tennessee LLC - November 16, 2017

An FDA inspection of Aphena Pharma Solutions-Tennessee, LLC in Cookeville, TN, a drug packager, revealed significant deficiencies in quality control unit procedures, including inadequate investigations and failure to address environmental excursions. The firm also lacked written procedures for critical production and process controls, and its facility had deficient areas for preventing contamination and mix-ups during packaging operations.