On August 26, 2013 the Department of Justice filed a lawsuit against the South Dakota-based company, Dakota Laboratories and its owner, Charles Voellinger. This is the latest action in the ongoing investigations of the FDA for problems with the manufacturer’s faulty production of eye drops. Starting with the warning letter in 2010, the FDA also found issues with the manufacturer in 2011 and 2012.
The FDA sent a warning letter in March 2011 clearly outlining each problem and telling the company what actions needed to be taken. “Your firm released several batches of sterile ophthalmic eye drops without adequately validating your aseptic process“. In addition, the company has reportedly failed to establish written specifications to assure lot sterility, and in at least one case did not test the sterility of water used in the manufacture of sterile eye drops. (Regulatory Affairs Professionals Society, 8/27)
The consent decree states that Dakota Laboratories, LLC and president, Charles L. Voellinger are prohibited from the manufacture and distribution of drugs until they correct violations of the drug manufacturing laws, the Current Good Manufacturing Practices (cGMPs). THE cGMPs were established to provide uniform regulatory practices for all drug makers—required under law as a way of standardizing and ensuring the manufacturing of safe and effective products. (FDA)
“The FDA had previously warned the company that corrective actions were necessary, and it ignored our warning,” said Melinda K. Plaisier, associate commissioner for regulatory affairs. “We took today’s action to assure that the firm puts controls in place to protect the public’s health.” (DOJ, Aug. 26, 2013)
The Department of Justice ruling requires Dakota Labs and its president to show compliance with the cGMPs, have an inspection by the FDA experts, and receive FDA authorization in order to resume operations.
“Consumers must be able to trust that drugs presented as sterile are, in fact, sterile,” said Stuart F. Delery, Assistant Attorney General for the Justice Department’s Civil Division. “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.” (DOJ, Aug. 26, 2013)
A consent decree is not issued lightly, it is the result of multiple attempts to get a manufacturer to fix production issues and comply with FDA regulations. Mr. Voellinger and his drug manufacturing business, Dakota Laboratories, have to show significant changes in their manufacturing process, including the implementation of sterility safeguards and appropriate testing of materials. As it turns out, however, the Dakota Laboratories is out of business, so correcting the problem for that entity would appear to be a moot point. Perhaps its poor quality control had something to do with the poor business model. It still faces the possibility of lawsuits and further legal action from the involved parties- the Department of Justice’s Consumer Protection Branch, Civil Division; the U.S. Attorney’s Office for the District of South Dakota, and FDA’s Office of the General Counsel.