According to a report published today, ANSM inspectors observed 24 deficiencies from good manufacturing practices (GMP) at the plant, which provides particle processing – micronization - services.
The major deviation was Anuh’s failure to pass details of its suppliers on to customers to which it sold processed active pharmaceutical ingredients (API).
The ANSM team also reported that azithromycin supplied to Europe labelled as being manufactured by Anuh was actually made by a non-compliant Chinese supplier called Hebei Dongfeng Pharmaceutical.
The inspectors also criticised Anuh’s document management practices after discovering several API repacking records and purchasing orders within a "pile of rubble on the other side of a wall."
They wrote that: “The findings reveal a critical non-compliance of the quality system of the company as a whole. Moreover, due to the severe lack of transparency of the company regarding its manufacturing activities, there is no assurance as regards to the origin of every batch of active substances claimed to have been manufactured by the company at the Boisar site.
“Consequently, it is considered that the identified risks are applicable to all active substances manufactured at the site.”
GMP certificate
The inspectors also suggested that “withdrawal of current valid EU GMP certificate issued by the Agencia Italiana del Farmaco (IT/E/GMP/9/2013)” be considered.
They also said: “The site has been issued a statement of non-compliance and active substances manufactured by the site should not be used for the manufacturing of medicinal products.”
The EDQM has yet to decide whether to withdraw CEPs issued to Anuh.