FDA 483 - International Isotopes Inc. - May 10, 2019

International Isotopes Inc. in Idaho Falls, ID, was cited for significant deficiencies in its manufacturing processes for I-131 Solution. Observations included unverified laboratory test methods, lack of water analysis for critical manufacturing water, and insufficient data to support reagent and buffer expiry dates. Additionally, the firm failed to investigate environmental excursions, had inadequate computer system controls allowing data deletion, and lacked a written SOP for its Quality Control Unit.