# FDA 483 - Kumar Organic Products Limited - April 21, 2023

Source: https://www.globalkeysolutions.net/records/483/kumar-organic-products-limited/2133156d-3c7c-4dd9-962f-fd315d7f2530

> FDA 483 for Kumar Organic Products Limited on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kumar Organic Products Limited
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Kumar Organic Products Limited in Vadodara, India, revealed a repeat observation concerning deficiencies in their materials system. The firm failed to adequately verify the reliability of component supplier's certificates of analysis, impacting products shipped to the United States. This indicates a significant issue with supplier qualification and quality control.

## Related Documents

- [WARNING_LETTER - 2019-11-14](https://www.globalkeysolutions.net/records/warning_letter/kumar-organic-products-limited/29efc231-5430-44ae-a659-7ef2b20f2780)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.globalkeysolutions.net/companies/kumar-organic-products-limited/07ad463c-e67e-4f49-a181-5a89e435be26

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