One More India-Based Drug Manufacturer Comes Under US Food And Drug Administration (FDA) Scrutiny

   on May 31 2013 7:21 AM

The U.S. Food and Drug Administration, or FDA, has issued a warning letter to pharmaceutical major Hospira Inc. (NYSE:HSP) following concerns about contamination of finished drugs at its manufacturing plant in southern India.

The warning to Hospira comes after two Indian pharmaceutical majors have recently faced FDA scrutiny over issues related to the quality of drugs and manufacturing practices.

The FDA said in its letter to Hospira that it found unhygienic practices in violation of quality regulations at its manufacturing facility in the southern state of Tamil Nadu.

"Surfaces are not always sanitized. ... Aseptic manufacturing intervention is not performed. ... Gloves used during manufacture of sterile products are used without adequate assurance of their sterility," the FDA letter said, according to a Times of India report.

The FDA’s letter followed an inspection of the company’s plant last October. The agency also asked the company to take measures to rectify the lapses and violations within 30 days.

Hospira, in a regulatory filing, confirmed the receipt of the warning letter from the FDA.

"We are in the process of reviewing the letter but do not believe that it significantly impacts either the scope or timing of our remediation efforts at IKKT or our other pharmaceutical manufacturing plants," a Hospira spokesman said, according to the Times of India report.

"Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter."

According to a Reuters report, Hospira has been facing several quality and regulatory issues at some of its manufacturing facilities, since 2010.

In February, the Lake Forest, Ill., firm had withdrawn its revenue forecast for 2013 after the FDA slapped an import ban on some of the products from its Costa Rica facility.

Hospira is the latest drug maker to come under FDA scrutiny for the violation of manufacturing and quality lapses at its Indian units.

Earlier this month, the Indian generic drug major Ranbaxy (BOM:500359) pleaded guilty to felony charges and agreed to pay $500 million as settlement to resolve civil and criminal charges brought against it.

Last week, the FDA issued an import alert on another Indian generic drug maker, Wockhardt (BOM: 532300), for violations in manufacturing processes at its Aurangabad plant in the western state of Maharashtra.

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