# FDA 483 - Goran Pharma Private Ltd - November 15, 2017

Source: https://www.keypedia.com/records/483/goran-pharma-private-ltd/db4984d7-0722-4b5d-818c-ff968df6d211

> FDA 483 for Goran Pharma Private Ltd on November 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Goran Pharma Private Ltd
- Inspection Date: 2017-11-15
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Goran Pharma Pvt Ltd in Sihor, India, revealed numerous significant deficiencies in their drug manufacturing operations. The firm lacked adequate microbiology laboratory facilities, failed to ensure proper personnel gowning, and did not consistently follow or establish written procedures for quality control, annual product reviews, and cGMP training. Critical issues were also identified in equipment maintenance, labeling control, water system integrity, supplier qualification, product release testing, and the overall stability study program for their drug products.

## Related Documents

- [483 - 2017-11-15](https://www.keypedia.com/records/483/goran-pharma-private-ltd/634a1387-a1d6-46b2-a06d-856cd962357e)

## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

Company: https://www.keypedia.com/companies/goran-pharma-private-ltd/266ed4ed-cf97-41cb-9979-f885ffb2f7e7

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321