The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December.
In total, AIFA cites the company for four critical and seven major deficiencies, including inadequate maintenance and cleaning; poor levels of training and awareness of good manufacturing practices (GMP); and insufficient environmental monitoring.
As a result of the findings, AIFA says it is prohibiting the supply of all drug substances and bulk drug products made at one of the buildings at the site, and is recommending that the European Directorate for the Quality of Medicines and Healthcare (EDQM) suspend ABL's certificate of suitability (CEP) for the antibiotic ceftazidime pentahydrate.
"ABL showed a poor level of training, low knowledge and awareness of GMP, lack of supervisors control and some non-authorised and fraudulent activities that were stopped before the inspectors came into the rooms," AIFA writes.
Additionally, AIFA says the company failed to implement a robust pharmaceutical quality management system.
"While ABL has many SOPs in place, during this inspection it was noted that procedures were not being robustly followed and related actions were not fully investigated, risk assessed, justified, and fully documented," AIFA writes.
AIFA also says the ABL staff "replied inconsistently" to requests and questions from the agency inspectors and noted that the company had not scheduled any training on European GMP, nor had it conducted a gap analysis between Brazilian and European GMP requirements.
AIFA's inspection came just one week after the US Food and Drug Administration (FDA) warned the company for the second time over GMP violations at the site.
In its latest warning letter, FDA cites ABL for failing to establish and follow procedures for preventing microbiological contamination and lacking an effective environmental monitoring system.
In light of the continued deficiencies at the facility, FDA recommended that ABL hire a consultant to assist with meeting GMP requirements and warned that failing to address the issues cited in the warning letter could lead to products made by the company being banned from the US.