Sterility Assurance of Parenteral Products Major Deficiency for Recall

Abstract

Lack of sterility assurance is a leading contributor to safety alerts and product recalls by Food and Drug Administration (FDA). Table 1 summarizes the safety alerts to parenteral products and drug manufacturers in 2016 [1]. Lack of sterility assurance can be product specific (probably caused by container closure integrity leakage) or manufacturing site specific (caused by poor facility and engineering or improper manufacturing practices) affecting all the drug products manufactured in the affected site. Such instances lead to major deficiencies during FDA facility inspections sometimes even leading to ceasing of all manufacturing operations until rectified [1-5].