FDA 483 - Overton Brooks VA Medical Center - February 03, 2020
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An FDA inspection of Overton Brooks VA Medical Center in Shreveport, LA, revealed significant deficiencies in their sterile drug product manufacturing operations. The facility's ISO 5 classified aseptic processing areas were located within unclassified rooms, and critical procedures like antechamber disinfection and continuous HEPA filtered air flow were not maintained. Additionally, equipment placement and overall facility design in segregated compounding areas were found to be unsuitable, posing risks to product sterility.
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