FDA 483 - Pharmakon Pharmaceuticals, Inc. - March 13, 2014

An FDA inspection conducted at Pharmakon Pharmaceuticals, Inc., an outsourcing facility, from March 5-13, 2014, revealed significant deficiencies in its manufacturing and quality control processes. The observations highlighted a critical lack of adherence to Current Good Manufacturing Practices (CGMP), particularly concerning the production of sterile drug products.Key violations included a failure to establish and follow adequate procedures to prevent microbiological contamination during aseptic processing, such as improper handling practices and insufficient validation of sterile operations. The facility also exhibited inadequate environmental controls, including issues with gowning, cleaning, disinfection, and a deficient environmental monitoring program that did not ensure aseptic conditions were consistently maintained.Furthermore, product testing and release procedures were found to be insufficient. The company released sterile injectable products prior to receiving sterility results, lacked essential method suitability and endotoxin testing, and failed to perform 100% visual inspections for contamination. There were also concerns regarding the lack of documentation for pyrogen-free components and the absence of appropriate segregation for manufacturing certain drug products like cephalosporins. Finally, numerous product labels did not comply with Section 503B(a)(10) of the Act, missing critical information such as the "compounded drug" statement, the facility's address, and dosage forms.Pharmakon Pharmaceuticals, Inc. is required to address these serious observations promptly by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and the safety and quality of its drug products.