FDA 483 - Epic Pharma, LLC - October 23, 2023

An FDA inspection of Epic Pharma, LLC in Laurelton, NY, from October 16-23, 2023, identified significant deficiencies in the firm's equipment cleaning and maintenance procedures. The observations included inadequate cleaning validation for drug products and tablet presses, as well as a lack of established cleaning times and documentation in several standard operating procedures. These issues indicate a lack of control over cleaning processes, raising concerns about potential product contamination and reproducibility.