DOJ files suit against plant with persistent issues

Being out of business is no guarantee that federal authorities will not seek a consent decree against a drug manufacturer, especially one that repeatedly fails to get sterility issues under control.

The Department of Justice (DOJ) has filed a lawsuit on behalf of the FDA against Mitchell, SD-based Dakota Laboratories and its owner Charles Voellinger. The suit came after inspections in 2010, 2011 and 2012 found significant manufacturing lapses in the plant's production of eye drops.

"We cannot take the chance that a manufacturer's failure to establish proper controls for sterile drug production could result in products becoming contaminated, placing consumers at risk of infection and potentially serious injury," Assistant Attorney General Stuart Delery said.

Dakota Laboratories settled the lawsuit by agreeing to a "Consent Decree of Permanent Injunction" that prohibits the facility from violating the federal food, drug and cosmetics act. The DOJ says the decree acknowledges that Dakota Laboratories is no longer in production. If its owners ever entertain thoughts of reopening, they must first get the FDA to sign off on the plant's production procedures.

The action came after FDA inspections initially found that Dakota Laboratories' procedures to protect against microbiological contamination were lacking and follow-up inspections found problems persisting. Among other issues, a 2011 FDA warning letter said the company had released several batches of sterile ophthalmic eye drops without adequately validating aseptic processes, and wasn't testing the water used to make the drops.

The FDA wheels out consent decrees only in the most serious cases in which ongoing efforts have been unable to get manufacturers to shape up. For example, in January Boehringer Ingelheim's contract manufacturing unit Ben Venue Laboratories' entered into a consent decree for its plant in Bedford, OH, after years of ongoing issues. Ben Venue issued 40 product recalls from 2002 to 2011. Ranbaxy Laboratories, India's generics giant, last year entered into a 5-year consent decree for two plants after the FDA found the company had been covering up serious manufacturing issues.

- here's the DOJ release
- see the 2011 warning letter