FDA 483 - InvaTech Pharma Solutions, LLC - February 05, 2019

InvaTech Pharma Solutions LLC, a drug manufacturer in East Brunswick, NJ, received a Form 483 with two observations during an FDA inspection. The firm failed to thoroughly investigate an unexplained discrepancy related to a batch of tablets and did not conduct documented annual cGMP training for its employees. These findings indicate deficiencies in the firm's quality system and personnel training.