FDA 483 - University of Alabama at Birmingham - August 27, 2019

The UAB Cyclotron PET Production Facility in Birmingham, AL, was cited for significant deficiencies in its PET drug manufacturing operations. Observations included inadequate record-keeping and data integrity controls for electronic records, unsuitable laboratory analytical methods, and a lack of robust production and process controls. Additionally, the firm failed to ensure equipment suitability and proper maintenance, and did not adequately review production records for errors.