# FDA 483 - Lupin Limited - January 10, 2020

Source: https://www.keypedia.com/records/483/lupin-limited/c1e1d43b-a1f0-48da-9195-f9a776d577b2

> FDA 483 for Lupin Limited on January 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2020-01-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Lupin Limited, a non-sterile drug manufacturer in Mihan, India, revealed significant deficiencies in their quality control processes. The firm failed to thoroughly investigate out-of-specification (OOS) results, often invalidating them without establishing a definitive root cause. Additionally, established laboratory control procedures for handling OOS results were not consistently followed by Quality Control personnel.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.keypedia.com/companies/lupin-limited/50f7d9dc-5597-42d6-b580-2154a13534ae

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