The facility in Visakhapatnam, India – known as Unit-2 – was issued with a Form 483 detailing six problems identified by US Food and Drug Administration (FDA) inspectors who audited the site between September 11 and 13.
In a Bombay Stock Exchange filing last week, Divi’s told investors the observations are "procedural" and that it will “be responding to these within the stipulated time.”
It explained that “The inspection was for full cGMP and verification of all Corrective Actions proposed against the previous inspection observations” adding that “all previous observations have been confirmed and resolved.”
Divi’s did not specify to which “previous inspection observations” it is referring or respond when we asked for more information.
Compliance history
The Unit-2 facility was landed with a US import ban in March. At the time, Divi’s said the alert had been issued under clauses 66-40 and 99-32 of US Food and Drug Administration (FDA) regulations.
A 66-40 import alert is issued when “inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).”
A 99-32 alert is issued to firms that have either refused to “permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel.”
In July, Divi’s said the US regulator was poised to lift the 99-32 import alert. The firm is no longer listed on the 99-32 alert page on the FDA’s website but is still liste on the 66-40 page.
European audits
The US FDA is not the only regulator to have visited the site.
In August, Divi’s said inspectors from Ireland’s HPRA and Slovenia’s JAZMP who audited the site the previous month had made “no critical observations.”