483
University of Alabama at BirminghamFDA 483 - University of Alabama at Birmingham - August 27, 2019
Record Details
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.
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ID · 6b82740d-7529-44dc-8ccb-02f745158ca5