# FDA 483 - Kumar Organic Products Ltd. - May 13, 2016

Source: https://www.globalkeysolutions.net/records/483/kumar-organic-products-ltd/6466d26f-fc41-4b83-8b22-be5d055289f7

> FDA 483 for Kumar Organic Products Ltd. on May 13, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kumar Organic Products Ltd.
- Inspection Date: 2016-05-13
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Kumar Organic Products Limited, an Active Pharmaceutical Ingredient Manufacturer in Bangalore, India, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas, including inadequate environmental controls, poor facility and equipment maintenance, insufficient cleaning validation programs, and unqualified utility systems. These issues indicate a lack of control over manufacturing processes that could impact API quality.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.globalkeysolutions.net/companies/kumar-organic-products-ltd/acc61a81-a684-4eb3-a4c8-d487dc0164e5

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