# FDA 483 - Lupin Limited (Biotech Division) - October 14, 2022

Source: https://www.keypedia.com/records/483/lupin-limited-biotech-division/fba695c4-7c84-4c77-be5a-4e943aef6afb

> FDA 483 for Lupin Limited (Biotech Division) on October 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited (Biotech Division)
- Inspection Date: 2022-10-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Lupin Limited (Biotech Division) in Pune, India, was inspected by the FDA from October 3-14, 2022, and received 18 observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, quality control, and facility maintenance for drug substance and drug product manufacturing. These issues indicate a lack of adequate controls to prevent contamination and ensure product quality and purity.

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## Related Officers

- [recipient](https://www.keypedia.com/people/yan-wang/9152655d-5458-4869-8e15-3227cec56699)
- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [company_representative](https://www.keypedia.com/people/li-yongmin/eb42eb61-6778-472f-b850-d043c2fe7d49)

Company: https://www.keypedia.com/companies/lupin-limited-biotech-division/71a104da-9365-4836-afc4-9c80c8a9c4f0

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd