FDA 483 - Iso-Tex Diagnostics, Inc. - February 10, 2023

An FDA inspection of Iso-Tex Diagnostics, Inc., a radiopharmaceutical manufacturer, was conducted from January 30 to February 10, 2023. The inspection documented numerous significant deficiencies in compliance with Current Good Manufacturing Practices (cGMP), particularly impacting sterile product manufacturing. A recurring observation highlighted the firm's failure to adhere to procedures preventing microbiological contamination, including poor aseptic techniques like exposed facial hair in critical clean areas, un-disinfected gloves, and obstructed airflow. Gowning practices were inadequate, with sterile gowns contacting the floor and re-gowning without proper glove use. The company also failed to sufficiently investigate and prevent microbial contamination, exemplified by the presence of a specific microorganism in ISO 5 cleanroom areas. Environmental monitoring systems were found lacking, with uninvestigated out-of-specification air changes per hour (ACH) and unqualified equipment. Cleaning and disinfection protocols were deficient, evidenced by foreign particulates on HEPA filters and poorly sealed light fixtures. Further issues included unhygienic washing facilities, inadequately cleaned equipment such as syringe trays, and failures in instrument calibration, including the use of expired sterile pipette tips. Critically, the facility's physical construction was unsuitable, featuring significant gaps in cleanroom doors and unsealed pass-throughs, compromising air quality control. Iso-Tex Diagnostics is required to provide a comprehensive response detailing its corrective and preventive actions to address these serious regulatory violations.