FDA 483 - AptaPharma Inc. - May 15, 2023

AptaPharma Inc. in Pennsauken, NJ, was inspected and received a Form 483 with six observations related to significant deficiencies in quality control, labeling, investigations, and warehousing practices. Key issues included inadequate investigations into product discrepancies like mislabeled "Alcohol Free" products, lack of control over labeling materials, and insufficient procedures for change control, audit trails, and environmental monitoring. The findings indicate a need for comprehensive improvements in the firm's quality systems and adherence to established procedures.