# FDA 483 - Emcure Pharmaceuticals Limited - May 15, 2026

Source: https://www.keypedia.com/records/483/emcure-pharmaceuticals-limited/08b85a58-35a5-4c21-8416-c2eeed65d6c2

> FDA 483 for Emcure Pharmaceuticals Limited on May 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emcure Pharmaceuticals Limited
- Inspection Date: 2026-05-15
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Emcure Pharmaceuticals Limited in Ahmedabad, India, revealed significant deficiencies in their drug manufacturing operations. The firm failed to adequately qualify equipment, thoroughly investigate product complaints, and maintain proper laboratory controls for raw materials. Critical issues were also identified in aseptic processing validation and contamination prevention for sterile drug products, alongside inadequate controls over computer systems and data integrity.

## Related Documents

- [483 - 2023-02-16](https://www.keypedia.com/records/483/emcure-pharmaceuticals-limited/e088335d-e023-45d7-8894-57c193d78aae)
- [483 - 2024-04-05](https://www.keypedia.com/records/483/emcure-pharmaceuticals-limited/c3e711b2-4931-42d8-9332-9ae339e29fb4)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/emcure-pharmaceuticals-limited/d1295106-bf79-46f5-bf51-08338508f98e

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3