# FDA 483 - Kumar Organic Products Ltd. - June 13, 2025

Source: https://www.globalkeysolutions.net/records/483/kumar-organic-products-ltd/f07e09d4-e486-4df3-a254-f8daeae6fd71

> FDA 483 for Kumar Organic Products Ltd. on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kumar Organic Products Ltd.
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Kumar Organic Products Ltd in Bangalore, India, an API manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures in quality unit responsibilities, inadequate OOS investigations and CAPAs, deficient complaint handling, poorly maintained manufacturing equipment, and an insufficient cleaning validation program. These issues indicate a systemic breakdown in ensuring product quality and safety.

## Related Documents

- [483 - 2016-05-13](https://www.globalkeysolutions.net/records/483/kumar-organic-products-ltd/6466d26f-fc41-4b83-8b22-be5d055289f7)
- [483 - 2019-02-04](https://www.globalkeysolutions.net/records/483/kumar-organic-products-ltd/b617b9ff-1ca7-4dc1-a0c4-c14536e79d6c)

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd