Urine spills stain Wockhardt’s image during FDA inspection

Mumbai: The Wockhardt Ltd plant that makes copies of a popular heart pill sold in the US turns out to be a jumble of dilapidated buildings with blighted windows connected by flaking pipes and capped by a rusty roof.

When US Food and Drug Administration (FDA) inspectors visited the factory that produces generic copies of the heart tablet Toprol-XL in July, they found urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area. They summarized their findings in a filing obtained by Bloomberg via a Freedom of Information Act request.

The document, known as an FDA Form 483, listed 16 so-called observations about Wockhardt’s factory in Chikalthana, 200 miles east of Mumbai, including concerns about quality control. While the FDA isn’t commenting on the possibility of enforcement action, such forms can be a prelude to export restrictions. A typical one contains only four to eight entries, said John Avellanet, managing director of Cerulean Associates Llc, an FDA compliance consultancy in Williamsburg, Virginia.

“This is very serious,” Avellanet said in an e-mail after reviewing the document. “Think of it as a giant vote of ‘no confidence’ from the FDA.”

As US regulators step up inspections, they’re finding more examples like Wockardt’s. The FDA has filed reports on four Indian facilities in the past six months and curbed exports at two drugmakers, including Ranbaxy Laboratories Ltd, the country’s largest. The findings highlight the contrast between immaculate headquarters like Wockhardt’s in Mumbai and working conditions at remote locations in India, where one-fifth of the world’s generics are made.

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