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483
•NOVA LABORATORIES LIMITED•August 23, 2024

NOVA LABORATORIES LIMITED – FDA 483, Aug 23, 2024

Record Details

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.

Company
NOVA LABORATORIES LIMITED
Inspection date
August 23, 2024
Product type
biologics
Office
Division of Blood Components and Devices
People
  • Gene D. Arcy
  • Feng Zhou
View Company Profile

ID · b780cc12-bd8d-4179-8e39-018af33718ff

Other documents for NOVA LABORATORIES LIMITED
  • EIR - 2019-03-12March 12, 2019

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