# FDA 483 - Shilpa Pharma Lifesciences Limited - July 26, 2019

Source: https://www.keypedia.com/records/483/shilpa-pharma-lifesciences-limited/fd49f65b-bc3e-4b76-adc1-a8ef8ac6c192

> FDA 483 for Shilpa Pharma Lifesciences Limited on July 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shilpa Pharma Lifesciences Limited
- Inspection Date: 2019-07-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of Shilpa Medicare Limited in Raichur, India, revealed significant deficiencies across quality systems, facilities, equipment, and laboratory controls. Key issues included inadequate investigations into out-of-specification results and power failures, missing manufacturing equipment, and poor equipment maintenance and cleaning validation. Additionally, the firm failed to validate computer systems and ensure proper instrument calibration and verification procedures, indicating a lack of robust control over critical API manufacturing and quality processes.

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## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/shilpa-pharma-lifesciences-limited/4f617c67-eea7-483d-b9c7-b1dd31aabcff

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