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A U.S. subsidiary of generic drugmaker Laurus Labs has been issued a Form 483 with one observation by the U.S. Food and Drug Administration (U.S. FDA) after a post-marketing adverse drug experience (PADE) inspection.
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The PADE inspection of the New Jersey-based wholly-owned foreign subsidiary Laurus Generics Inc. included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Laurus Labs marketed products worldwide.
The inspection was conducted for four days between January 13 and 21. “We have been issued a Form 483 with one observation and the company will address the said observation within stipulated timelines,” Laurus Labs said in a filing.
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Published – January 22, 2025 06:40 pm IST
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Laurus Labs arm gets one U.S. FDA observation after post-marketing adverse drug experience inspection
