# FDA 483 - Virupaksha Organics Limited - February 07, 2025

Source: https://www.keypedia.com/records/483/virupaksha-organics-limited/84fa1357-f6df-47a4-a2bd-8a155c1d42f1

> FDA 483 for Virupaksha Organics Limited on February 07, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Virupaksha Organics Limited
- Inspection Date: 2025-02-07
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: **FDA 483 Summary for Executives**

**Company Name:** Virupaksha Organics Limited, Unit-I  
**Inspection Dates:** February 3-7, 2025  
**Location:** Sangareddy District, Telangana, India  
**Type of Establishment:** Manufacturer of Intermediate and Active Pharmaceutical Ingredients (APIs)  

**Main Violations/Issues:**  
During the inspection conducted by the FDA, a significant labeling violation was identified. The active pharmaceutical ingredients (APIs) shipped to the United States lacked the required Caution Statement and Rx legal requirement on their finished product labels. This omission was noted in multiple lots manufactured in September 2023, with a retest date of August 2028. The absence of these critical labeling components raises concerns about the intended usage and regulatory compliance of the products shipped to the US.

**Regulatory Framework:**  
The inspection was conducted under the regulatory framework governing pharmaceutical manufacturing practices, specifically focusing on compliance with US labeling requirements for APIs intended for the US market.

**Required Actions:**  
Virupaksha Organics Limited is expected to address the labeling deficiencies by ensuring that all API products shipped to the US include the necessary Caution Statement and Rx legal requirements. The company is advised to discuss any objections or corrective actions with the FDA representatives or submit this information to the FDA at the provided contact details. Prompt corrective measures are essential to align with US regulatory standards and prevent potential disruptions in product distribution.

**Contact Information:**  
For further inquiries or submission of corrective action plans, the company should contact the FDA at the provided address or email.

## Related Documents

- [483 - 2025-02-03](https://www.keypedia.com/records/483/virupaksha-organics-limited/7e769fae-f739-49ff-8ac7-47e00c004a7c)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa