# FDA 483 - Virupaksha Organics Limited - February 03, 2025

Source: https://www.globalkeysolutions.net/records/483/virupaksha-organics-limited/7e769fae-f739-49ff-8ac7-47e00c004a7c

> FDA 483 for Virupaksha Organics Limited on February 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Virupaksha Organics Limited
- Inspection Date: 2025-02-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Virupaksha Organics Limited, Unit-I in Sangareddy, India, identified a significant labeling deficiency. The firm shipped active pharmaceutical ingredients (API) to the US without the required Caution Statement and Rx special legal requirement on the finished product labels. This indicates a serious non-compliance with labeling regulations for pharmaceutical products.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.globalkeysolutions.net/companies/virupaksha-organics-limited/ec60074b-409a-445c-87a4-2172dffbe8b1

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