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

Source: https://www.keypedia.com/records/483/neuland-laboratories-limited-unit-ii/2af59f72-4493-4231-8649-9a46b8a0f3ae

> FDA 483 for Neuland Laboratories Limited (Unit II) on May 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neuland Laboratories Limited (Unit II)
- Inspection Date: 2025-05-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Mabany Lizardi](https://www.keypedia.com/people/mabany-lizardi/adcca71c-e996-44e5-9827-d1aa2773e832)
- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.keypedia.com/companies/neuland-laboratories-limited-unit-ii/77d9ed2b-f8c4-47e5-9c2a-f44225476b20

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1