# FDA 483 - Lupin Limited - April 07, 2017

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/a2721371-e28c-4093-bd85-0657e5aed2a8

> FDA 483 for Lupin Limited on April 07, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2017-04-07
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of Lupin Limited in Verna, India, revealed significant deficiencies across its quality control, production, and process control systems. The firm failed to thoroughly investigate out-of-specification results, often invalidating them without scientific justification or adequate corrective actions. Additionally, the inspection found inadequate procedures for hold time studies, process validation, and monitoring of manufacturing processes, including issues with data integrity in in-process testing.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/andrew-j-idzior/5b639c02-d062-4a5a-aa4a-8362ddfba2b6)
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Company: https://www.globalkeysolutions.net/companies/lupin-limited/218ee27f-639e-4fc4-995c-345bc58c3548

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552