# FDA 483 - Marksans Pharma Limited - Unknown Date

Source: https://www.keypedia.com/records/483/marksans-pharma-limited/80682a11-b730-4fb9-a552-18a7a51d9dcd

> FDA 483 for Marksans Pharma Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marksans Pharma Limited
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Marksans Pharma Limited, a non-sterile drug manufacturer in Verna, Goa, was cited for eight observations during an FDA inspection. The findings primarily concern deficiencies in quality control unit responsibilities, stability programs, change control for packaging, complaint investigations, microbial testing procedures, laboratory controls, and cleaning procedures. These issues indicate a lack of robust quality systems to ensure product quality and compliance with cGMP regulations.

## Related Documents

- [483 - 2023-08-04](https://www.keypedia.com/records/483/marksans-pharma-limited/7e072b93-a247-49bb-a6f3-6a6e0f4a83e5)

## Related Officers

- [Susanna E. Ford](https://www.keypedia.com/people/susanna-e-ford/4332d436-f50b-4657-9d85-93c10bfe0cc8)
- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd