Kumar Organic Products LimitedApril 21, 2023

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Kumar Organic Products Limited

Record Details

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.

Company: Kumar Organic Products Limited
Inspection Date: April 21, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Patty P. Kaewussdangkul (Investigator)

Open in Dashboard

ID · 2133156d-3c7c-4dd9-962f-fd315d7f2530