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US FDA conducts pre approval inspection at Laurus Labs' facility

US FDA conducts pre approval inspection at Laurus Labs' facility

Laurus Labs has informed that US Food and Drug Administration (USFDA) has completed a PreApproval Inspection (PAI) at the company's manufacturing facility at Unit-5, Parawada, Visakhapatnam, Andhra Pradesh.

The inspection was conducted from October 24, 2022 to October 28, 2022, the company said.

The company has been issued a Form 483 with one observation. The observation is procedural. Further, the company informed it will address the observation within stipulated timelines.
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Laurus Labs Pharma QC US FDA
More news about: quality / gmp | Published by Sudeep Soparkar | October - 31 - 2022 | 1126

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