# FDA 483 - Emcure Pharmaceuticals Limited - April 05, 2024

Source: https://www.keypedia.com/records/483/emcure-pharmaceuticals-limited/c3e711b2-4931-42d8-9332-9ae339e29fb4

> FDA 483 for Emcure Pharmaceuticals Limited on April 05, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emcure Pharmaceuticals Limited
- Inspection Date: 2024-04-05
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Emcure Pharmaceuticals Limited in Charal, Gujarat, India, was inspected from March 28 to April 5, 2024. The inspection revealed one observation concerning the firm's failure to establish and follow procedures for instrument calibration and preventive maintenance for microbiological testing equipment. This issue impacts the reliability and accuracy of microbiological test results, as the firm relies solely on vendor qualification.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)
- [Xiaokuang Lai](https://www.keypedia.com/people/xiaokuang-lai/6c25851d-0954-4f42-8f14-c2e0382e6815)

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