Neuland Laboratories Limited (Unit II)May 2, 2025

FDA 483 - Neuland Laboratories Limited (Unit II) - May 02, 2025

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Record Details

An FDA inspection of Neuland Laboratories Limited (Unit II) in IDA Pashamylaram Village, India, revealed significant deficiencies in facility design and construction. The firm failed to adequately prevent potential cross-contamination of active pharmaceutical ingredients (APIs) due to inadequate controls, shared corridors, and insufficient cleaning validation. This indicates a serious concern regarding the integrity and safety of their manufactured APIs.

Company: Neuland Laboratories Limited (Unit II)
Inspection Date: May 2, 2025
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Mabany Lizardi
Rowena S. Nguyen

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ID · 2af59f72-4493-4231-8649-9a46b8a0f3ae