Laurus Synthesis Private Limited (LSPL), a fully-owned subsidiary of Laurus Labs, has recently undergone an inspection by the US Food and Drug Administration (FDA) for its manufacturing facility located in Parawada, Anakapalli, near Visakhapatnam, Andhra Pradesh. The inspection spanned from December 4, 2023, to December 12, 2023.
Following the inspection, LSPL has received a Form 483 with five observations from the FDA. The company is committed to promptly addressing these observations within the stipulated timelines. The Form 483 is a standard form issued by the FDA to notify companies of any deviations or concerns observed during inspections. Laurus Labs aims to ensure compliance with regulatory standards and maintain the highest quality standards in its manufacturing processes.
Laurus Labs, a multinational pharmaceutical and biotechnology company based in Hyderabad, India, specialises in active pharmaceutical ingredients, generic formulations, custom synthesis, biotechnology, veterinary APIs, and agrochemicals.
