# FDA 483 - Marksans Pharma Limited - August 04, 2023

Source: https://www.keypedia.com/records/483/marksans-pharma-limited/7e072b93-a247-49bb-a6f3-6a6e0f4a83e5

> FDA 483 for Marksans Pharma Limited on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marksans Pharma Limited
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Marksans Pharma Limited in Vasco Da Gama, Goa, India, identified significant deficiencies in the firm's adverse drug experience (ADE) reporting and post-marketing surveillance systems. The company failed to submit required 15-day reports for serious and unexpected ADEs found through literature searches. Additionally, the firm lacked comprehensive written procedures for managing ADEs, including those from literature, contracted vendors, online sources, and for signal detection.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/marksans-pharma-limited/80682a11-b730-4fb9-a552-18a7a51d9dcd)

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.keypedia.com/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)
- [Dawn C. Olenjack](https://www.keypedia.com/people/dawn-c-olenjack/b5a18d10-cd4b-405e-9016-8f5274a33000)

Company: https://www.keypedia.com/companies/marksans-pharma-limited/0855d225-2181-468a-a51c-c479608c1c92

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4