Indian Sterile Facility in a Dilapidated Condition

In October 2022, Madhu Instruments Private Limited in India received a Warning Letter from the FDA due to unsanitary conditions discovered during an inspection. Issues included peeling paint, obstructed airflow from a covered HEPA filter, broken tiles, and oil-soiled areas. Despite terminal sterilization, the FDA emphasized the necessity of proper equipment maintenance to prevent contamination.

The manufacturer admitted to inadequate cleaning and updated their Standard Operating Procedures (SOPs). However, the FDA noted a lack of retrospective risk assessment and an insufficient cleaning program. Consequently, the FDA issued the Warning Letter and imposed a US import ban, underscoring their commitment to product safety and quality standards.

The FDA's actions highlight the importance of maintaining stringent cleanliness standards in manufacturing facilities to ensure the safety of consumer products. Such measures are crucial to prevent contamination and uphold public health. The FDA continues to monitor and enforce regulations to safeguard consumers and maintain the integrity of the supply chain.