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

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

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)
View Company Profile

ID · e077f27e-e6e9-430b-93a3-b8b529bf8eb7

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