# FDA 483 - Lupin Limited - October 18, 2018

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/b652c954-f2ff-4c65-8d9f-10f5f29884ed

> FDA 483 for Lupin Limited on October 18, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2018-10-18
- 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 its drug manufacturing operations. Observations included inadequate process performance qualification, deficient cleaning validation for multi-use rooms and equipment, and poor controls over computerized systems in the QC laboratory. Additionally, the firm's sampling procedures for APIs and acceptance procedures for incoming devices were found to be inadequate.

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## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.globalkeysolutions.net/companies/lupin-limited/d2616722-956d-4898-88a7-c22b7bd321a2

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