THE US FDA has issued a warning
about drugs made at Ranbaxy’s
factory in Mohali, India, with the
move seeing shares in the company
dive 35%.
Under the FDA “import alert,”
US border officials may detain
any products originating at the
plant, with the organisation saying
Ranbaxy would remain on the
banned list until it complies with
Good Manufacturing Practices.
Other Ranbaxy facilities in Dewas
and Paonta Sahib have been on
FDA import alert since 2008.
The latest move follows
inspections which identified
significant GMP violations at
Mohali, with some reports saying
a tablet was found to contain
an “embedded black fibre that
could have been a hair from an
employee’s arm”.
Ranbaxy said it would review the
alert and “take all necessary steps
to resolve the concerns”.The above article was sent to subscribers in Pharmacy Daily's issue from 20 Sep 13 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 20 Sep 13
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