U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Kumar Organic Products Limited - 598683 - 07/24/2023
  1. Warning Letters


Kumar Organic Products Limited MARCS-CMS 598683 —

Reference #:
FEI 3009167769

Recipient Name
Mr. K. K. Singh
Recipient Title
Kumar Organic Products Limited

Plot No. 379 Canal Road
Maitri Marg, Village Luna, Taluka Padra District
Vadodara 391440

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Dear Mr. Singh:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-34 dated April 23, 2020.

Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.

The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations and/or deviations be observed during a subsequent inspection or through other means.

Michael Klapal
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

Back to Top