Cross-Contamination issues at Indian pharmaceutical manufacturer

The FDA inspected Granules India Limited from 26 August to 6 September 2024 and identified serious GMP violations.

1. Cleaning and Maintenance: Contamination was found in ventilation ducts due to inadequate cleaning. Swab samples showed drug residues and high microbiological loads. The company’s MACO calculations were deemed insufficient and incorrect by the FDA.
2. Facility Maintenance: The FDA observed contamination from bird droppings in production areas. HVAC systems were poorly maintained, leading to filter failures and leaks, which increased contamination risks. The FDA emphasized the need for better inspections and preventive actions.
3. Data Integrity: The inspection uncovered torn GMP documents and poor data management practices. The company’s SOPs were inadequate for ensuring data integrity, prompting the FDA to request a full review of practices.

The FDA requires the company to take corrective actions and improvements. The full warning letter is available on the FDA website.

05-05-2025