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An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.
FDA investigators found violations of CGMP at the Hikma Farmaceutica (Portugal) manufacturing facility for finished pharmaceuticals, according to an FDA warning letter dated Oct. 21, 2014. Violations included failure to conduct thorough investigations of environmental monitoring excursions in Class 100 aseptic production areas and failure to establish adequate written procedures for production and process control.
Procedural issues included failure to provide adequate challenge test-set vials to qualify operators and quality assurance staff to perform visual inspection of drug products. FDA called for the company to describe the actions implemented to ensure that finished parenteral drugs are essentially free of particulate matter and to provide an assessment of quality system procedures to detect quality defects in marketed products. FDA noted that Hikma was previously cited during a September 2011 inspection for failing to detect and evaluate particulates.