FDA WARNING_LETTER - Madhu Instruments Private Limited - October 21, 2022

On February 1, 2024, the FDA issued a Warning Letter to Madhu Instruments Private Limited, New Delhi, India, following an inspection from October 11-21, 2022. The FDA determined that (b)(4) manufactured at the facility were adulterated under section 501(a)(2)(A) of the FD&C Act, as they were prepared, packed, or held under insanitary conditions, potentially leading to contamination or rendering them injurious to health.

The inspection revealed a facility in disrepair, lacking adequate controls to prevent product contamination. Specific observations included visibly dirty manufacturing equipment, including (b)(4) machines stained with oil or grease, and soiled masking tape and printer paper used in product handling and packaging.

Madhu Instruments' November 11, 2022, response to the FDA Form 483 was deemed inadequate. While the company acknowledged an inadequate cleaning and sanitization SOP and improper preventive maintenance, and implemented a new checklist and revised SOPs, their response failed to include a retrospective review and risk assessment of product quality and contamination. Despite terminal sterilization, the FDA emphasized the need for proper facility design and maintenance to prevent extraneous particulate contamination.

The FDA placed the firm on Import Alert 66-40 on May 31, 2023. The company must promptly correct all violations and respond in writing within 15 working days, detailing