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Tuesday, September 17, 2019

FDA gets injunction against Ohio drug maker

By Stephanie Ostrowski | Feb 12, 2013

WASHINGTON (Legal Newsline) - A drug manufacturer has been hit with a permanent injunctoin after the Food and Drug Administration found procedures were not followed to prevent contamination of sterile drugs.

In the complaint filed by the United States, the FDA inspected the Bedford, Ohio-based Ben Venue Laboratories from Nov. 7 to Dec. 2, 2011, and found violations including failure to properly clean and maintain equipment to ensure the safety and quality of the sterile drugs it manufactures, among other violations.

In addition, the FDA stated that the company failed to conduct an adequate investigation of its drugs that did not meet its specifications.

Ben Venue manufactures numerous generic sterile injectable drug products which include cancer medications.

The consent decree of permanent injunction was ruled by U.S. District Court Judge Leslie Wells at the request of the FDA.

The permanent injunction announced by the Department of Justice also was entered against George P. Doyle, president and chief executive officer, Kimberly A. Kellemann, vice president of operations, and Douglas A Rich, vice president of quality operations.

According to the complaint, the problems have been reoccurring.

During the FDA's May 2011 inspection, 48 deviations from good manufacturing practices including an inadequate quality control unit, insufficient and untimely investigations, poor designed aseptic processing area and employee practices, failure to prevent microbial contamination of drug products, and failure to determine the root cause for microbial contaminants.

Furthermore, the FDA and Ben Venue's history includes 35 inspections since 1997 with approximately 40 recalls since February 2002.

According to the consent decree, to resume operation Ben Venue must create and implement a remediation plan and hold an inspection by the FDA to confirm manufacturing processes a full compliant with the law.

Under the decree, Ben Venue may continue to manufacture and distribute a subset of their dugs which are currently under a shortage according to the FDA. However, before distribution the company's expect must conduct a batch-by-batch review and certify that no deviations occurred during the manufacturing of the drug that could affect the safety or quality.

"This consent decree restricts Ben Venue from manufacturing and distributing certain drugs until the company fully complies with the law," said Stuart F. Delery, Principal Deputy Assistant Attorney General for the Justice Department's Civil Division. "As this case demonstrates, the Department of Justice and FDA will work together to protect the health and safety of Americans by making sure that those who produce and distribute prescription drugs follow the law."

FDA regulations establish minimum current good manufacturing practices which require manufacturers to control all aspects of the process and procedures by which drugs are manufactured in order to prevent unsafe and ineffective products from being produced.

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