STAT+: FDA cites Indian ingredients supplier for deleting records

One might think that a pharmaceutical ingredients company that boasts clients in 80 countries, certification from several regulators and employs some 1,400 “fully trained” workers shouldn’t have anything to hide.

But that’s not what inspectors from the U.S. Food and Drug Administration found when they visited a Global Calcium plant in Bangalore, India, last summer, according to a Jan. 16 warning letter the agency sent the company. And the various manufacturing breaches that were uncovered by agency staffers underscores ongoing concerns over the quality of products made by India’s pharmaceutical industry.

Upon arriving last July at the facility, the FDA inspectors initially saw Microsoft Excel documents on a desktop computer in a production office. But the next day, the files — some of which pertained to cleaning validation samples and production reports — had been deleted, which meant the FDA inspectors could not verify if the company was adhering to manufacturing standards.

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