Indian generic drug manufacturer has thrown away truckloads of important documents

Amid ongoing concerns about the quality of drugs manufactured in India, a major generic drug company was seen dumping three truckloads of “scrap” from a factory that was inspected by the US Food and Drug Administration (FDA) last month.

Specifically, “large quantities of torn paper” were found in the trucks and in a garbage bag at a Granules facility in Telangana, India, containing documents that were supposed to be kept to document manufacturing and testing procedures. When confronted by FDA inspectors, factory management admitted that the papers should not have been destroyed.

In describing the incident, FDA inspectors found that the quality control unit lacked oversight and management of documents that are “critical to ensuring that the drugs manufactured and tested at your site are safe and effective.” The findings were contained in a so-called 483 inspection report, which was largely redacted but also cited concerns about contamination.