# FDA 483 - Cadila Pharmaceuticals Limited - January 20, 2023

Source: https://www.keypedia.com/records/483/cadila-pharmaceuticals-limited/5962c1e6-00e1-4d6f-9684-015dde5a5a4c

> FDA 483 for Cadila Pharmaceuticals Limited on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cadila Pharmaceuticals Limited
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Cadila Pharmaceuticals Limited in Ankleshwar, Gujarat, India, revealed a significant issue with laboratory controls. The firm failed to establish the sensitivity of test methods, specifically regarding the determination of chromatographic purity for intermediates. This indicates a deficiency in ensuring the accuracy and reliability of analytical testing procedures.

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/cadila-pharmaceuticals-limited/4da00d50-12de-4f58-8c9c-5933664b3ffe

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