The Wall Street Journal reports:
NEW DELHI—Workers at a Ranbaxy Ltd. drug plant repeatedly fudged test results to make it appear that raw materials and active pharmaceutical ingredients met required standards when they didn't, according to a report by inspectors from the Food and Drug Administration.
FDA officials visited Ranbaxy's Toansa factory in the northwestern Indian state of Punjab early this month and said they discovered workers retesting "until acceptable results are obtained" and deleting evidence of failed tests.
The FDA inspectors also noted that analytical and microbiological laboratories at the plant were in "significant disrepair," with windows that couldn't close and a sample-preparation room with flies that were "too numerous to count."
In one lab, the FDA report said, inspectors "identified the presence of numerous sticky notes" that were found to "contain instructions for corrections to be made to the raw data" for testing. The inspectors also wrote that they had observed a worker in the quality-control lab backdating a log entry.
"We immediately questioned this analyst regarding the reason for backdating his record, who responded that he had only entered '2014,' despite our visual observation of him entering a signature and full date entry a few moments earlier," the report said.
