FDA BI injunction

February 1, 2013

THE US Food and Drug Administration has obtained a permanent injunction against Boehringer Ingelheim’s Ben Venue Laboratories, restraining the firm from manufacturing and distributing drugs from its Bedford, Ohio facility until a range of issues are addressed. The FDA found that Ben Venue and three of its staff failed to comply with good manufacturing practices, with recent inspections citing several quality problems incl particles in some sterile products, and “basic facility cleaning and maintenance issues”. The company repeatedly failed to comply with issues which had been raised by inspectors, with Ben Venue unable to operate until the FDA determines that the facility complies with regulations.

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Pharmacy Daily | FDA BI injunction

FDA BI injunction

Other recent headlines

Peters wins top fellowship

Botanix listed on All Ords

3D films target tumours

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES