# Zydus Pharmaceuticals Limited – FDA 483, Sep 28, 2026

Source: https://www.keypedia.com/records/483/zydus-pharmaceuticals-limited/8e9ca000-ac13-4130-b170-efe188be485c

> FDA 483 for Zydus Pharmaceuticals Limited on September 28, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Pharmaceuticals Limited
- Inspection Date: 2026-09-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zydus Pharmaceuticals Limited in Ahmedabad, India, a drug manufacturer, was cited for significant deficiencies in its laboratory controls. The firm failed to establish scientifically sound specifications and procedures, specifically omitting microbiological testing for certain drug products throughout their manufacturing process. This raises concerns about the quality and purity assurance of their pharmaceutical products.

## Related Officers

- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)
- [Sara H. Gabel](https://www.keypedia.com/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)

Company: https://www.keypedia.com/companies/zydus-pharmaceuticals-limited/a915c687-5359-4e95-b6bc-b2e6a506ca52

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