FDA 483 - Stokes Healthcare Inc. dba Epicur Pharma - October 25, 2023

During an inspection from September 26 to October 25, 2023, the FDA observed significant deficiencies at Stokes Healthcare Inc. dba Epicur Pharma, an outsourcing facility in Mount Laurel, NJ. The inspection revealed widespread issues including unvalidated manufacturing processes for sterile drug products, inadequate aseptic processing controls, failures in quality control investigations, and non-compliant drug product labeling. These findings indicate a serious lack of adherence to cGMP requirements, particularly concerning the production and release of sterile human and animal drug products.