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Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, received a warning letter from the FDA citing significant cGMP and data integrity issues discovered at its manufacturing plant. Read More
Akorn Pharmaceuticals continued drug production when equipment malfunctions would normally require it to abort the batch, the FDA said in a Form 483. Read More
Nippon Fine Chemical impeded a December 2015 inspection, the FDA said in a warning letter that claims employees blocked access to certain areas, refused to provide documents and prevented inspectors from taking photos. Read More
Violations of quality control standards for finished pharmaceuticals led to an FDA warning letter for Mappel Industria, a Brazil-based company. Read More