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
BREAST Cancer Network Australia (BCNA) has welcomed a PBAC recommendation to subsidise the breast cancer drug Enhertu (trastuzumab deruxtecan) for HER2-low metastatic breast cancer on the PBS.
PHARMACY Connect (PC2024) has revealed that Olympian Peter Bol will be sharing his journey from adversity to athletic greatness at the conference in Sep in Sydney.
IN WESTERN Australia, Michael’s Chemist Group has started stocking therapeutic Nicotine Vaping Products (NVPs), pursuant to the Federal Government’s new vaping laws (PD 25 Mar).
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