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.The above article was sent to subscribers in Pharmacy Daily's issue from 01 Feb 13 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 01 Feb 13
THE Australian Government has lowered the age of eligibility for its free National Bowel Cancer Screening Program (NBCSP) to 45, unlocking access to the test kits to more than 1.6 million Australians.
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