RadioMedix, Inc. – FDA EIR, Mar 24, 2022

RadioMedix, Inc. underwent an FDA pre-approval inspection from March 15 to March 24, 2022, focusing on their Abbreviated New Drug Application (ANDA) for a Positron Emission Tomography (PET) drug. The inspection evaluated compliance with current Good Manufacturing Practices (cGMP) under regulatory framework CP 7346.832. Six significant deficiencies were identified. Key issues included inadequate aseptic practices within cleanroom operations, such as inappropriate equipment and non-sterile glove use, alongside structural problems like unsealed ceiling tiles in critical classified areas. The firm also failed to adequately establish comprehensive batch records, lacking crucial details on production limits, material specifications, and yield calculations. Furthermore, RadioMedix did not perform incoming identity testing for essential raw materials, nor did it ensure the quality of certain components met established requirements for validation batches. A critical finding was the failure to qualify a supplier for a key drug component before its use. Upon conclusion, the FDA issued a 6-item Form 483 detailing these observations. RadioMedix management acknowledged the findings and stated they were actively addressing the deficiencies, including revising master batch records, updating cleaning procedures, refining cleanroom recertification processes, and initiating the qualification of suppliers for critical materials to ensure compliance. The overall PET drug manufacturing profile was deemed unacceptable.