# FDA 483 - Lupin Limited - September 16, 2025

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/ddecc276-a606-460a-97e9-4234974fdb50

> FDA 483 for Lupin Limited on September 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2025-09-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Lupin Limited in Nagpur, India, received a Form 483 with six observations during an inspection from September 5-16, 2025. The observations primarily concern significant deficiencies in aseptic processing validation, environmental monitoring, quality control procedures, and stability testing methods for sterile drug products. These issues indicate a lack of adequate controls to prevent microbiological contamination and ensure product quality and data integrity.

## Related Documents

- [483 - 2025-09-08](https://www.globalkeysolutions.net/records/483/lupin-limited/5620dc63-71de-4bcc-b3e2-8bf62be5f613)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/lupin-limited/0486e3a3-7887-41ff-9908-811e2a997f4e)

## Related Officers

- [Kendra A Boyd](https://www.globalkeysolutions.net/people/kendra-a-boyd/ff77a27d-0753-4708-a685-57e45a9a9e56)
- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)
- [investigator](https://www.globalkeysolutions.net/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)
- [Hung H. Do](https://www.globalkeysolutions.net/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.globalkeysolutions.net/companies/lupin-limited/b6e6db97-9d2a-4714-887a-0d966c3815c0

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8