French regulators have warned the European Medicines Agency (EMA) that a sterile manufacturing operation in Brazil has some significant problems and its products should be evaluated closely by each country until its issues can be resolved.
Inspectors from France’s National Agency for Medicines and Health Products Safety reported that they uncovered the problems at the Nova DFL Industrie plant in Rio de Janeiro during an inspection Feb. 2 and the plant is not meeting GMP standards.
The facility tallied up seven critical deficiencies, including “high” risks for microbial contamination and an operator failing to sterilize a tool for grabbing vials after it had fallen on the floor. There was also a danger of cross-contamination, and operators were not testing all API batches but claiming on certificates of analysis that they had been.
The inspection had been requested by the company, which was hoping to get approval in Europe for a new sterile drug. Inspectors said they were told the company has yet to find an EU customer for the drug, but the French regulator recommended the product be kept out of European markets until problems at the plant are resolved. It also said each country should carefully evaluate any other products they currently receive from the DFL Industrie plant.
A series of EMA and FDA actions have been taken in the last year against Brazilian drugmakers. In January, the FDA issued a second warning letter to a Sao Paulo plant of antibiotics maker Antibioticos do Brasil. Days later, the EMA also took action against the company.
Last fall, the FDA also issued a warning letter to Mappel Indústria de Embalagens, also of Sao Paulo. The drugmaker responded by telling the FDA that it did not fully comprehend that its products would be regulated by the FDA as OTC drugs and so had changed its mind about selling them in the U.S.