Regulatory Focus™ > News Articles > After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ

After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ

Posted 27 August 2013 | By Alexander Gaffney, RAC

In February 2013, the US Department of Justice (DOJ) announced it would be making the enforcement of the US Food and Drug Administration's (FDA) current good manufacturing practices (CGMPs) one of its "top areas of focus" for 2013. And while the ultimate effects of that effort have yet to be realized, at least one pharmaceutical manufacturer is now feeling the brunt of DOJ's enforcement activities.

Bad Inspections

In a 26 August 2013 announcement, DOJ said it has filed a lawsuit against Dakota Laboratories LLC and its owner, Charles Voellinger Sr., for allegedly violating CGMPs in the manufacture of sterile eye drops. The lawsuit, filed on behalf of FDA, came after FDA inspectors discovered "significant violations" of CGMP practices during a June 2010 inspection of the company's Mitchell, S.D. manufacturing facility.

Those violations, the Warning Letter explained, were principally concerned with aseptic manufacturing. "Your firm released several batches of sterile ophthalmic eye drops without adequately validating your aseptic process," FDA wrote in the March 2011 Warning Letter. 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.

That inspection had followed a deficient 2010 inspection, and a subsequent 2012 inspection led to FDA filing a complaint against Dakota.

Terms of Consent Decree

"Consumers must be able to trust that drugs presented as sterile are, in fact, sterile," said Stuart 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's statement says that Dakota has agreed to enter into a Consent Decree of Permanent Injunction that will prohibit it from future violations of the Federal Food, Drug and Cosmetic Act (FD&C Act)-perhaps something of a moot point since the company has apparently shut its doors for good. But even if it reopened, DOJ said it would be required to first obtain approval from FDA that its manufacturing operations met CGMP regulations.


DOJ Statement


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