WSJ: U.S. Wockhardt plant accused of employing an unapproved method to test drug quality

NEW DELHI — Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.

Citing inspection documents released on the FDA website, the WSJ reported that Wockhardt employees used "trial injections," in which early sample tests of the drugs were taken before the official recorded quality test.

The Morton Grove plant produces roughly half of the drugs the company sells in the United States, according to the WSJ report.

According to the FDA's website, FDA regulators found appropriate controls were not exercised over computers or related systems at the Chicago plant, meaning any user could change or delete data stored on them. Further, staff was not properly trained under current good manufacturing practices, the website showed. In addition, the FDA's investigator observed an employee entering the manufacturing area of the plant without washing and sanitising his hands.

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