FDA 483 - Aurolife Pharma, LLC - October 22, 2019

The FDA inspected Aurolife Pharma LLC, Inc. in Dayton, New Jersey, and identified significant deficiencies in their manufacturing and quality control systems. Key issues included undefined quality unit responsibilities, incomplete laboratory records for reference standards, and inadequate process control procedures. The firm also failed to establish appropriate specifications and test procedures, utilized unsuitable analytical methods, and had deficient complaint handling processes, leading to numerous product defect complaints.