India’s Wockhardt has received an FDA warning letter for a plant in the U.S., making an even half-dozen warning letters for seven Wockhardt plants, three of which have been banned from shipping to the U.S.
Wockhardt reported to the Bombay Stock Exchange on Wednesday that the FDA has issued the warning letter to its Morton Grove Pharmaceuticals in Illinois, north of Chicago. It said that it has been working for months, with the help of consultants, to address the issues the FDA raised.
Wockhardt claimed the warning letter would not restrict the flow of existing drugs but will keep it from launching any new products from the facility in Morton Grove, Illinois. The facility makes a variety of products, including cough syrups and an acetaminophen and codeine combo pain med.
The FDA has yet to make the letter public, but the plant received a Form 483 in 2014 that was issued after an FDA inspection that went on for 17 days. The plant was criticized for many of the same issues that the FDA had already found in its plants in India.
The agency cited the facility for unsanitary conditions and poor employee sanitation, but focused on its “uncontrolled use of 'trial' injections during chromatographic testing” to achieve passing tests for drug releases. The FDA said the plant continued the practice even after the FDA had noted the same issue in warning letters issued to two other Wockhardt facilities in India.
One of Wockhardt’s warning letters dates back to 2006, but two were received in 2013, including one letter covering two plants, and two were issued in 2016, including one for a sterile manufacturing facility in the U.K. Three of its plants in India are on the FDA's import alert list, meaning they are unable to ship products to the U.S.
Needless to say, the company's growing regulatory problems have taken a financial toll. For its quarter ended Dec. 31, 2016, the company reported sales of about $161 million, down 22%, while its after-tax profit was down 82% for the quarter and 24% for the first nine months of the fiscal year.