# Seema International – FDA 483, May 21, 2025

Source: https://www.keypedia.com/records/483/seema-international/396d537c-9c0c-4e37-a389-b713ef2d1cfb

> FDA 483 for Seema International on May 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seema International
- Inspection Date: 2025-05-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Seema International, a drug product manufacturer, repackager, and relabeler in New Delhi, India, revealed severe and systemic deficiencies in their quality system, facilities, equipment, production, packaging, labeling, material, and laboratory controls. Many observations were repeats from a 2018 inspection, highlighting a persistent failure to establish and follow basic GMP requirements, including the absence of a functional quality control unit and inadequate employee training. These findings indicate a critical lack of oversight and control over drug product quality and safety.

## Related Documents

- [WARNING_LETTER - 2025-05-21](https://www.keypedia.com/records/warning_letter/seema-international/b56e47e3-6b8e-47d8-bb24-9be785ec418d) — date: May 21, 2025

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/seema-international/8758202e-7949-4f36-af3b-04dada4668ca

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8