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The agency is following up on a February 2016 inspection of the facility that found GMP violations.
The European Medicines Agency (EMA) is reviewing drug products manufactured by Pharmaceutics International Inc., USA after a February 2016 inspection by the Medicines & Healthcare products Regulatory Agency (MHRA) found GMP violations. EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the findings of the inspection to evaluate the benefits and risks of the company’s products and make recommendations on any possible changes to their marketing authorization.
The MHRA inspection, which was a follow up to a June 2015 inspection, assessed the corrective actions taken by the company. MHRA found “insufficient measures to reduce the risk that traces of one medicine could be transferred to another (cross-contamination), as well as problems with the way data were generated and checked and deficiencies in the systems for ensuring medicines’ quality (quality assurance),” according to an EMA press release.
According to EMA, while there is no current patient risk, the company’s products will no longer be supplied in the European Union unless considered critical to public health. National medicines regulatory agencies will assess the criticality of the medicines.