483
NOVA LABORATORIES LIMITEDFDA 483 - NOVA LABORATORIES LIMITED - August 23, 2024
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An FDA inspection of Nova Laboratories Ltd in Wigston, Leicestershire, revealed significant deficiencies in their manufacturing operations. The firm failed to maintain equipment and utensils at appropriate intervals to prevent contamination of sterile drug products. Additionally, the company did not adequately qualify the airflow effectiveness in critical manufacturing areas, raising concerns about environmental control and product quality.
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