Sun Pharma brought in consultants last year and invested in new systems at its Halol plant, all in an effort to overcome FDA concerns about its operations. But it was not enough, India’s largest drugmaker acknowledged today. A recently completed FDA reinspection of the plant ended with more citations.
Sun, in a terse filing (PDF) with the Bombay Stock Exchange, said today that a “Form 483 observation letter was issued by the FDA post the inspection,” which was completed Dec. 1. It said the company was responding to the FDA concerns.
It was another tough blow for the drugmaker, which has seen its U.S. revenues suffer since the FDA first raised concerns in 2014 about the plant, one of Sun’s primary sources for U.S. drugs. The agency last year slapped the plant with a warning letter that cited the plant for a variety of issues, from not having controls on computers to keep data from being altered by employees, to a leaky ceiling that could contribute to production contamination.
Sun has been able to ship products from the facility but is prevented from launching any new products from the Halol site. The drugmaker last month reported results for the first half of its fiscal year, saying that sales in the U.S. were up 17% to about $1.2 billion but said that growth primarily resulted from its 180-exclusive sale of a generic of Gleevec, a top-selling Novartis product. Sun was forced to shift production of the generic out of Halol to another facility in order to make its U.S. debut.