Amid ongoing concern over the quality of medicines made in India, a major supplier of generic medicines was seen removing three truckloads of “scrap materials” from a facility that was being inspected last month by the Food and Drug Administration.
Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana, India. And when confronted by the FDA inspectors, the plant management acknowledged the papers should not have been destroyed.
In describing the episode, the FDA inspectors noted that the quality control unit lacked oversight controlling and managing documents that are “critical in ensuring drug products manufactured and tested at your site are safe and effective.” The findings were contained in a so-called 483 inspection report that was largely redacted, but also referenced concerns about contamination.
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