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# CGMP Issues at Kumar Organic Products
- URL: https://www.fdaweb.com/cgmp-issues-at-kumar-organic-products/
- Published: 2020-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:15:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146815

An 11/11-11/14/19 FDA inspection at Kumar Organic Products, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 4/23 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kumar-organic-products-limited-598683-04232020?ref=fdaweb.com) says specific violations were: 

- failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance; and
- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals.

The letter says that based on the nature of the violations identified at the firm, FDA strongly recommends engaging a qualified consultant to assist it in meeting CGMP requirements. Kumar was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the steps.