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Antibioticos Do Brasil Ltda. Gets Ema Non-Compliance Report

Brazilian manufacturer of sterile products, Antibióticos Do Brasil Ltda. received a non-compliance report. The company specializes in manufacturing generic antibiotics cephalosporin, injection solutions, powder injection, and capsules. The API manufacturer was inspected by the Italian supervisory agency "Italian Medicines Agency".

During the inspection, four critical and seven major deficiencies were observed. As a consequence, a prohibition of supply for all products produced at the inspected site was suggested, as well as a suspension of the CEP (Certification of Suitability).

Non-compliance reports are published in the EudraGMDP database of the European Medicines Agency (EMA) by European supervisory authorities. They refer to inspections inside as well as outside of the European Union. The non-compliance reports are independently submitted into the database by National Competent Authorities via a standardised form. For the company concerned, a non-compliance report has severe consequences until the violations are rectified. Amongst other things, a suspension of the marketing authorisation as well as recalls of the products in question could be mandated.

Critical deficiencies:

Major deficiencies:

IGMPI

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