# FDA 483 - Sanjay Ramteke, M.D. - May 23, 2025

Source: https://www.keypedia.com/records/483/sanjay-ramteke-md/c46c371c-82cf-4500-911f-2c30905020b7

> FDA 483 for Sanjay Ramteke, M.D. on May 23, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanjay Ramteke, M.D.
- Inspection Date: 2025-05-23
- Product Type: Drugs
- Office Name: Foreign - CDER (Bioresearch Monitoring)
- Summary: The FDA conducted an inspection of Dr. Sanjay Ramteke's clinical investigation site in Nagpur, Maharashtra, India, from May 19 to May 23, 2025. The inspection focused on compliance with the investigational plan for a clinical study. A significant violation was identified: the failure to discontinue the investigational product for a subject who developed neutropenia, an adverse event of special interest. Despite the subject's neutrophil levels dropping significantly, the investigational product was not halted, and the subject continued to receive infusions.

This oversight contravenes the investigational plan and raises concerns under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, specifically Section 704(b). This section mandates that any observed conditions potentially rendering a product injurious to health must be reported. The FDA's observations are intended to assist the firm in achieving compliance with applicable regulations.

The FDA requires Dr. Ramteke to address these observations by implementing corrective actions. The firm is encouraged to discuss objections or corrective measures with the FDA during the inspection process or submit them in writing. The FDA's findings are preliminary and do not constitute a final determination of compliance.

## Related Documents

- [483 - 2025-05-23](https://www.keypedia.com/records/483/sanjay-ramteke-md/65f50d7f-c028-4f23-bbf2-5c5ff29c1c4f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)

Company: https://www.keypedia.com/companies/sanjay-ramteke-md/2e6168cd-a15f-4e94-a1c7-4a50d3d4501e

Office: https://www.keypedia.com/offices/foreign-cder-bioresearch-monitoring/d1dedffd-4125-4ced-a8fd-dc65ee0cac8a