The US Food and Drug Administration (FDA) has finally visited a India-based generic drug manufacturing facility, Ranbaxy Laboratories, which was linked to several deaths in the United States due to contaminated generic blood thinner shots. The inspection was carried out in May 2014, almost a year after the FDA sent a warning letter to the company in June 2013.
The FDA’s visit to the factory in Gurgaon, India, uncovered significant problems, including poor manufacturing practices, inadequate quality control, and failure to comply with good manufacturing practices (GMPs). The FDA’s report highlighted numerous deficiencies, including:
1. Contamination: The FDA found evidence of contamination in the facility, including dust, debris, and chemicals, which could compromise the sterility of the products.
2. Inadequate sterility testing: The FDA found that the company was not performing adequate sterility testing on its products, including injectable products, which put patients at risk.
3. Inadequate cleaning and sanitizing: The FDA found that the company’s cleaning and sanitizing procedures were inadequate, which could lead to the introduction of contaminants into the products.
4. Failure to document records: The FDA found that the company’s records were incomplete and did not provide sufficient documentation of its manufacturing processes, quality control measures, and product testing.
5. Inadequate training: The FDA found that the company’s employees had not received adequate training on GMPs, which could lead to errors and contamination.
The FDA’s findings are significant, as an estimated 21,000 vials of contaminated Heparin, a blood thinner, were imported from India and sold in the US between 2001 and 2008, resulting in significant health problems and at least 81 reported cases of adverse reactions, including stroke, kidney failure, and even deaths.
The FDA’s inspection of Ranbaxy’s facility is a significant step towards ensuring that the company meets international standards of quality and safety. However, the findings highlight the need for greater oversight and regulation of foreign-based pharmaceutical manufacturers to prevent similar incidents in the future. The FDA has given the company 15 months to correct the deficiencies and pending the successful resolution of the issues, the agency may remove the import alert and allow the company to resume exporting products to the US.