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# ‘Insanitary Conditions’ at Madhu Instruments
- URL: https://www.fdaweb.com/insanitary-conditions-at-madhu-instruments/
- Published: 2024-02-13T12:00:00.000Z
- Updated: 2026-09-14T14:22:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156342

A 10/11-10/22/2022 FDA inspection at the Madhu Instruments Private Limited drug manufacturing facility in New Delhi, India, found that redacted drug products were adulterated in that they had been prepared, packed, or held under insanitary conditions in which they may have been contaminated with filth or been rendered injurious to health. A 2/1 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/madhu-instruments-private-limited-659694-02012024?ref=fdaweb.com) lists some of the conditions the investigators found and says, “You do not have adequate controls in place to maintain a suitable production environment and prevent contamination of products manufactured at your facility.”

FDA says the firm acknowledged that its cleaning and sanitization standard operating procedure was inadequate and the facility preventive maintenance plan was not implemented properly. “You implemented a new checklist to verify and monitor cleaning and sanitization of the manufacturing areas and revised your standard operating procedures for cleaning,” the letter says. “Your response is inadequate because you failed to conduct a retrospective review and assessment of the risks to product quality, including all potential contamination risks. Previously you had committed to improving your cleaning procedures but thus far have not adequately developed a cleaning and sanitization regimen that minimizes the risk of contamination.”

The agency placed Madhu on a 5/31/2023 import alert. It was told to promptly correct violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.