June 3, 2014 / 4:50 PM / in 4 years

FDA criticizes quality control, training at Wockhardt U.S. plant

MUMBAI (Reuters) - The U.S. healthcare regulator has found fault with quality control, training and staff hygiene at Wockhardt Ltd’s plant in Chicago, potentially adding to regulatory problems facing the Indian generic drugmaker.

The U.S. Food and Drug Administration (FDA) listed its concerns after inspecting the Chicago facility from Jan 22 to March 26. The FDA’s finding were posted on the FDA website on May 30, and seen by Reuters on Tuesday.

The FDA found responsibilities and procedures applicable to the quality control department at its Chicago-based Morton Grove Pharmaceuticals business were not made in writing and fully followed at the facility.

A spokesman for Mumbai-based Wockhardt declined to comment on the FDA findings when contacted by Reuters.

Wockhardt, which has faced a spate of regulatory sanctions for poor production processes at some of its plants in India, was also criticised for not conducting training to ensure good manufacturing practices at the plant.

Morton Grove accounts for more than 50 percent of Wockhardt’s sales in the United States. The U.S. market is Wockhardt’s biggest, accounting for 45 percent of sales in the fiscal year to March.

Wockhardt’s managing director Murtaza Khorakiwala said last week that FDA had expressed concerns over production processes at the U.S. unit. He said the company had responded to the observations but declined to give details.

If the FDA is not satisfied with the response, it could ban production from the Morton Grove plant.

The FDA investigator said in a letter to Morton Grove that was posted on the regulator’s website: “Your firm’s quality unit is not fully monitoring quality systems designed to assure the safety and quality of drug products manufactured by your firm.”

According to the website, the regulator also found appropriate controls were not exercised over computers or related systems at the Chicago plant, potentially allowing any user to change or delete data stored on them.

A review of training records of five staff revealed that two did not have “documented training” in the FDA’s so-called current good manufacturing practices, the website showed.

Also, the FDA’s investigator observed an employee entering the manufacturing area of the plant without washing and sanitising his hands.

    Concerns over quality control in India’s $15 billion drug industry surfaced in the past year after plants run by Ranbaxy Laboratories and Wockhardt were banned from exporting to the U.S. for falling short of the FDA’s production practices.

That has hurt India’s reputation as a supplier of safe, affordable drugs. Indian drug exports grew by just 2.6 percent in the 2013/14 fiscal year ended in March. Two years ago, the growth rate was 23 percent.

Reporting by Sumeet Chatterjee. Editing by Jane Merriman

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