| MUMBAI, June 3
MUMBAI, June 3 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)