# FDA 483 - Lupin Limited - January 25, 2019

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/8b88d5f5-75e2-41be-9892-f5839389f067

> FDA 483 for Lupin Limited on January 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2019-01-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Lupin Limited in Pithampur, India, revealed significant deficiencies across multiple areas of drug manufacturing. The firm failed to adequately investigate out-of-specification results and customer complaints, lacked proper employee training and management oversight, and demonstrated poor control over computer systems and equipment validation. These issues indicate a systemic breakdown in quality control and data integrity practices.

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## Related Officers

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Company: https://www.globalkeysolutions.net/companies/lupin-limited/8707ad63-3e60-4c11-9138-77be2a49865c

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