A federal judge has approved a permanent injunction restricting a generic drug company from manufacturing and distributing certain drugs until it complies with the law, the Justice Department said Thursday.
The DOJ said the company, Ben Venue Laboratories, has been the subject of about 40 recalls since 2002, including 10 each in 2011 and 2012.
The Bedford, Ohio, company is a subsidiary of Ingelheim, German-based Boehringer Ingelheim.
The DOJ, which sought the injunction at the Food and Drug Administration's request, said Ben Venue manufactures generic sterile injectible drug products, including cancer medications. According to the agency's Jan. 22 complaint, a November-December 2011 inspection documented 10 deviations from good manufacturing practices, and the findings were similar to several previous inspections at Ben Venue's facility.
According to the complaint, the FDA found during the 2011 inspection that the company failed to create and follow appropriate procedures to prevent contamination of drugs that were purported to be sterile.
It found that the company failed to properly clean and maintain its equipment to ensure the safety and quality of the drugs it manufactured, and that it failed to conduct adequate investigations of drugs that did not meet their specifications.
The DOJ said some of the recalls involved drugs contaminated with glass and other particulates, while additional recalls were based on the company's inability to assure the drugs' sterility.
In addition to the company, the consent decree including the permanent injunction named George P. Doyle, the company's president and CEO; Kimberly A. Kellerman, its vice president of operations; and Douglas A. Rich, vice president of quality operations.
The consent decree approved by U.S. District Court Judge Lesley Wells requires Ben Venue to take a wide range of actions to correct its violations and ensure they do not happen again, the DOJ said in a statement. It establishes a series of steps that must occur before Ben Venue can fully resume operations, including retaining an expert to inspect the company's facility, developing and implementing a remediation plan, and the FDA inspecting the site to confirm that the company's manufacturing processes fully comply with the law.
The DOJ said the company is permitted to continue to manufacture and distribute a number of its drugs that the FDA has determined are in shortage or vulnerable to shortage. However, prior to distribution of each batch, the company's expert must certify that no deviations occurred during the manufacturing that would adversely affect their safety or quality.
“This resolution comes following nearly three dozen inspections which revealed inadequate quality control, including contaminated drugs and led to approximately 40 recalls on products from this facility alone,” said Steven M. Dettelbach, U.S. attorney for the Northern District of Ohio. “The Justice Department and the Food and Drug Administration will continue to place its highest priority on protecting consumers.”
In a statement released the same day the complaint was filed, the company said it is “permitted to continue to manufacture and distribute more than 100 important drugs that are essential for patient care and to continue its drug-development activities.
“To date, Ben Venue has invested more than $300 million to upgrade its facilities, making necessary improvements and changes to processes to address the manufacturing-related issues that have resulted in the company's decision to voluntarily halt manufacturing in November 2011,” according to the statement. “Ben Venue has demonstrated progress in improving manufacturing processes, and announced in October 2012 that limited production had resumed. Since that time, production has resumed on additional manufacturing lines.
“Ben Venue, in partnership with the FDA, is committed to addressing drug shortage and ensuring critical medicines reach the people who need them. We continue to work closely with the FDA and share the goal of returning to production to manufacture safe and effective medicines.”