FDA and EMA both hammer Brazilian sterile antibiotics maker over contamination concerns

Sterile manufacturing at Antibioticos Do Brasil plant in Sao Paulo.

A Brazilian antibiotics maker that was hammered in an FDA warning letter issued last month also caught the attention of the European Medicines Agency, which has banned its products because of concerns over the sterile manufacturing plant’s standards.

In fact, many of the issues noted by Italian inspectors during a December 12 inspection of the Antibioticos Do Brasil facility had been laid out in an FDA warning letter issued days before, the second for the Sao Paulo plant, which had also been cited in a 2009 FDA warning letter.

The FDA, which inspected the facility in April 2016, had noted that sterile areas didn’t have unidirectional airflow in sterile filling areas that could protect products from contamination. The agency also had concerns about other procedures to monitor for and protect aseptic filling areas from microbiological contamination. The agency recommended the company bring in experts to help it figure out how to meet standards.

Italian inspectors tallied four critical and seven major deficiencies at the plant, hammering the antibiotics maker for not keeping sterile manufacturing areas clean or safe from potential contamination.

Among the long list of problems inspectors noted was that plant employees in general didn’t seem to be trained or aware of GMP methods and there were few supervisors to oversee their work. They found the quality management system weak, data collection poor and “anomalous events had not been appropriately investigated and documented.”

The inspectors also noted that the company did not have any training on the differences in requirements for products being shipped into the EU versus the standards in Brazil.

Besides banning Antibioticos Do Brazil from shipping sterile drugs into the EU, the European Medicines Agency has suspended its certificate of manufacturing for sterile production. It said the facility would have to go through another inspection, showing the deficiencies had been corrected, to regain its status in the EU.