Laurus Labs Limited (Unit-5)October 28, 2022

FDA 483 - Laurus Labs Limited (Unit-5) - October 28, 2022

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Record Details

During an inspection of Laurus Labs Limited, Unit-5 in Anakapalli, India, the FDA observed a significant deficiency related to facility conditions. Specifically, the firm failed to provide adequate lighting in a critical solvent dispensing area used for intermediate and API manufacturing. This issue could impact the safety and quality of pharmaceutical production.

Company: Laurus Labs Limited (Unit-5)
Inspection Date: October 28, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Nadeem I. Chaudhry (Consumer Safety Officer)

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