Italy has banned APIs made by Antibioticos do Brasil LTDA (ABL) at its facility in Bairro Itapavussu, Sao Paulo over sterility concerns.
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.
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