# FDA 483 - Concord Biotech Limited - May 02, 2025

Source: https://www.keypedia.com/records/483/concord-biotech-limited/ca5090cf-c290-4f3a-a498-cd2fd7f95cba

> FDA 483 for Concord Biotech Limited on May 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Concord Biotech Limited
- Inspection Date: 2025-05-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Concord Biotech Limited in Dholka Ahmedabad, India, revealed significant deficiencies in manufacturing practices for Active Pharmaceutical Ingredients (API). Observations included inadequate equipment cleaning, insufficient laboratory controls for microbiological testing verification, and poor data integrity controls for computerized systems. Additionally, the firm failed to properly monitor and control water quality used in API manufacturing steps.

## Related Documents

- [483 - 2025-05-02](https://www.keypedia.com/records/483/concord-biotech-limited/296b34ca-b96e-4974-96dd-24f5ea592a21)

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/concord-biotech-limited/84ea17c0-5c3b-40cc-9098-13c3031fe2dc

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1