FDA 483 - Penta Manufacturing Company - February 16, 2024

Penta Manufacturing Company, an API repacker/relabeler in West Caldwell, NJ, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate cleaning and sanitization of utensils, insufficient COA documentation, lack of stability studies and unsupported retest dates, and a complete absence of master production instructions, quality unit procedures, and proper material testing protocols. These issues indicate a severe lack of quality control and good manufacturing practices.