# FDA 483 - Neuland Laboratories Limited (Unit I) - June 21, 2019

Source: https://www.keypedia.com/records/483/neuland-laboratories-limited-unit-i/aa82ff67-fa6e-4140-a7f8-35b538357150

> FDA 483 for Neuland Laboratories Limited (Unit I) on June 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neuland Laboratories Limited (Unit I)
- Inspection Date: 2019-06-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Neuland Laboratories Limited (Unit I) in Sangareddy, India, an Active Pharmaceutical Ingredient Manufacturer, was cited with five observations during an FDA inspection. The inspection revealed significant issues across data integrity, water system validation, equipment cleaning, and stability study procedures. These failures indicate a lack of adherence to established procedures and inadequate investigation and prevention of deviations.

## Related Officers

- [investigator](https://www.keypedia.com/people/nije-a-thomas/3d1ede3c-d04e-4c2e-a9a8-61261f4d44b5)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/neuland-laboratories-limited-unit-i/2ab72f34-8d5a-4919-8777-83a4fa3cadd5

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