Wockhardt U.S. plant nailed by FDA in a warning letter

Wockhardt's India headquarters building
India's Wockhardt has received an FDA warning letter for a plant in the U.S.

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. 

Survey

Survey: The Critical Role of Innovation in Launching Successful OTC Products

This research aims to understand the importance of product innovation and dose forms in driving new product design and development, consumer engagement and purchase interest for Over-the-Counter medicines. The first 50 qualified respondents will receive a $5 Amazon gift card. Take the survey now.

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.

Read more on

Suggested Articles

Hikma says it has picked up some pipeline products and nasal and sublingual spray equipment from Insys Therapeutics' bankruptcy.

WuXi Biologics expects to have a plant in Europe complete in 2021 as a capacity race plays out among Asia’s rapidly growing biologics CDMOs.

After five years of struggles, Sun Pharmaceutical has put the problems at its key plant in Halol, India behind it.