FDA EIR - Midwest Medical Isotopes LLC - August 13, 2014

An FDA inspection of Midwest Medical Isotopes LLC, a manufacturer of sterile injectable PET drugs, was conducted from August 4 to August 13, 2014. This initial pre-approval inspection, following FDA's PET cGMP guidelines, uncovered numerous significant deficiencies. The company was not registered with the FDA as a drug establishment, a process they began during the inspection. Key violations, detailed in an FDA-483, included the lack of established quality assurance procedures for product release and cGMP documentation control, along with inadequate environmental and personnel monitoring in critical production areas. The firm used non-sterile disinfectants and lacked validated sterility and endotoxin testing methods. Further issues encompassed insufficient documentation practices, such as failing to record the preparation of laboratory standards, perform growth promotion testing for all media lots, and calibrate essential equipment. Batch records lacked actual product labeling and descriptions of unit dose syringes, and the lot numbers for certain raw materials were not documented. Critically, the firm had not established action limits for radiochemical yield, and written procedures for material receipt, testing, and acceptance were inadequate. The Medical Director, Dr. George N. Chacko, acknowledged the observations and committed to providing a written response within 15 business days, promising corrective actions for all identified issues. The FDA warned of potential sanctions, including the disapproval of pending Abbreviated New Drug Applications.