German company Fresenius has had a string of warning letters in the past several years for manufacturing problems at plants in the U.S., Puerto Rico and India. As a director of project management for 6 years in North America, Ronald Hillier says he pointed out issues at some of the plants that he believed could result in contaminated products. Instead of taking him seriously, the former employee claims the company canned him.
Hillier has responded with a state whistleblower lawsuit in Cook County in Chicago, alleging retaliation by the company, according to Crain's Chicago Business. Fresenius declined to comment on the litigation.
Hillier, who worked for the generic drug division Fresenius Kabi from 2006 until his termination in January 2012, was in charge of making sure the company's manufacturing practices were safe and followed state and federal laws. He said that in 2010, he expressed concerns about a manufacturing plant in suburban Chicago to the chief operating officer of the company. Instead of taking him seriously, he claims the company moved him to a facility in Puerto Rico. After pointing out potential problems again, the company moved him to a facility in New York, demoted him, and eventually let him go.
A month after Hillier says he was fired, the FDA sent a warning letter to Fresenius for contamination concerns at its plant in Grand Island, NY, operated by its subsidiary APP Pharmaceuticals ($APPX). The observations, which were based on inspections in 2011, included insects found in the sterile manufacturing area. The company said that it believed the insects were introduced by the manufacturer of stoppers used in its vials at the time, but the FDA pointed out that it took 16 months for the company to audit the stoppermaker. The warning letter also raised questions about heparin manufacturing at that plant.
The problems in New York are not isolated. Last year the FDA sent Fresenius a warning letter for a plant in India and another for labeling problems at a blood-products plant in Puerto Rico. In July, the company's oncolytic API plant in Kalyani, India, was savaged in a warning letter that said employees lied about having blended APIs that failed quality tests into batches that passed in an effort to hit specifications. It documented employees confessing to manipulating data to hide problems and saying they had removed computers prior to inspections to "conceal data manipulations." The company blamed problems on management at the facility. Its solution? It fired them.
- read the Crain's Chicago Business story