# FDA 483 - Lupin Limited (Unit II) - December 04, 2018

Source: https://www.keypedia.com/records/483/lupin-limited-unit-ii/01157280-eaec-44ff-b43a-16ebb2d2c1c2

> FDA 483 for Lupin Limited (Unit II) on December 04, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited (Unit II)
- Inspection Date: 2018-12-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Lupin Limited (Unit II) in Mandideep, India, revealed significant deficiencies in manufacturing practices. The firm was cited for inadequate cleaning validation processes for equipment, insufficient performance qualification of water treatment systems, and a lack of proper Quality Unit oversight. Additionally, the inspection found that user access controls for computerized SCADA systems were not adequately defined.

## Related Documents

- [483 - 2018-12-04](https://www.keypedia.com/records/483/lupin-limited-unit-ii/b09f1e38-a914-4fdb-9847-5df7978fbedd)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Christopher S. Sealing](https://www.keypedia.com/people/christopher-s-sealing/5b3881d8-86b5-4fac-9798-43969ed8c77b)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/lupin-limited-unit-ii/0e413a24-2509-480e-8fc5-4b107772370e

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