483
NOVA LABORATORIES LIMITEDFDA 483 - NOVA LABORATORIES LIMITED - August 23, 2024
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An FDA inspection of Nova Laboratories Ltd in Wigston, United Kingdom, revealed two significant observations concerning manufacturing controls. The firm was cited for inadequate maintenance of equipment and utensils to prevent contamination of drug products. Additionally, the inspection found that the firm had not properly qualified airflow effectiveness in critical manufacturing areas, raising concerns about the sterility and quality of its products.
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ID · e967beca-887b-4e23-ad75-b6d3159d1203