FDA 483 - Appco Pharma LLC - August 19, 2022

Appco Pharma LLC, a drug manufacturer in Piscataway, NJ, was cited for multiple deficiencies related to environmental control, quality unit oversight, and inventory management. The inspection revealed significant issues with monitoring and documenting temperature and humidity conditions for stability samples, manufacturing areas, and storage locations. Additionally, cleaning procedures for equipment were inadequate, and the quality unit failed to ensure proper oversight and investigation of environmental excursions.